HealthyPhase 1NCT04107441

AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects

A Phase 1 study testing AX-8 Part 1 and AX-8 Part 2 in people with Healthy, run by Axalbion SA at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of the study is to see how safe the study drug AX-8 is and how well it is tolerated when administered at different dose levels in healthy participants. The study will also investigate pharmacokinetics (PK), i.e how the study drug is taken up, metabolized (broken down) and eliminated. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: AX-8 Part 1 and AX-8 Part 2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited Kingdom
Study dates: 9 Sep 2019to 4 Mar 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female volunteers aged ≥ 18 and ≤ 55 years at the time of informed consent
Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method
Female subjects (regardless of childbearing potential) must agree not to donate ova/oocytes during the study from the first dosing day and until 30 days after the last dose
Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success, or use highly effective contraception together with their female partner(s)
Male subjects must agree not to donate sperm during the study from the first dosing day and until 90 days after last dose
Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at Screening

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Have provided written informed consent
Are willing and able to comply with all aspects of the protocol
Normal electrocardiogram (ECG) and vital signs (or abnormalities which the clinical Investigator considers the deviation to be irrelevant for the purpose of the study) during screening and prior to first dose
Laboratory values within the normal range (or the clinical Investigator considers the deviation to be irrelevant for the purpose of the study) during screening
Findings within the range of clinical acceptability in medical history and physical examination (or the clinical Investigator considers the deviation to be irrelevant for the purpose of the study)

Who cannot join

Prior treatment with AX-8
Hypersensitivity or intolerance to transient receptor potential melastatin subfamily, member 8 (TRPM8) agonists (e.g. menthol, menthol-derivatives, eucalyptol) or any of the excipients of the AX-8 tablets
Current smoker or individuals who have given up smoking for less than 12 months or ex smoker with > 10 pack-years
History of upper or lower respiratory tract infection within 4 weeks prior to screening or prior to first dose.
Requiring concomitant therapy with prohibited medications
Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer, prior to screening

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Treatment with any investigational therapy within 4 weeks prior to screening
Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > the upper limit of normal (ULN) during screening
Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or antibodies against human immunodeficiency virus 1 or 2 (HIV-1 and HIV-2 Abs) during screening
Positive tests for drugs of abuse or alcohol breath test at screening or prior to first dose
History of malignancy, with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, within 5 years prior to screening
History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt
Presence of any medical condition or disability that, in the Investigator's opinion, could interfere with the assessment of safety or efficacy in this study or compromise the safety of the subject
History or presence of alcoholism or drug abuse within the past 2 years prior to screening
Females who are currently pregnant, breastfeeding or lactating, or who have a positive pregnancy test at screening or prior to first dose
Male subjects with a pregnant, breastfeeding or lactating partner or a partner who is planning to become pregnant during the study or within 90 days after the last dose
Donation of blood (≥ 400 mL) or plasma, or significant blood loss within 56 days prior to screening

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Medicines Evaluation Unit (MEU) Ltd
Manchester, M23 9QZ

Other trials in United Kingdom

About this study

Official title: A Phase 1 Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Twice Daily Administration of AX-8 Tablets in Healthy Volunteers in a Single-Centre

The main purpose of the study is to see how safe the study drug AX-8 is and how well it is tolerated when administered at different dose levels in healthy participants.

The study will also investigate pharmacokinetics (PK), i.e how the study drug is taken up, metabolized (broken down) and eliminated.

Read the detailed description

The primary objective of the study is to investigate the safety and tolerability of ascending AX-8 oral doses, i.e. orally disintegrating tablets (ODTs), administrated twice for one day (Day 1) in healthy participants.

The secondary objectives are to investigate the pharmacokinetic (PK) profile and the subjective sensory attributes (e.g. basic tastes, palatability, cooling) of ascending AX-8 oral doses (ODTs), administered twice for one day in healthy participants.

The study consists of two parts.

Part 1

The first part of the study (Part 1) is an ascending dose, open-label, single center study in healthy participants. Part 1 will consist of a Screening Period (Days -28 to -1) to assess eligibility to participate in the study, 4 Treatment Periods (Day 1 to Day 2; one overnight stay for each treatment period) with a minimum washout period of 48 hours between doses (however a longer period will be required for dose escalation / safety review decisions, as required) and a Follow-Up Visit 7 to 14 days post last dose.

During each treatment period, participants will be admitted to the study center on the morning of Day 1 and discharged from the study center on the morning of Day 2 (i.e. after the pre-discharge procedures have been performed). Participants will attend a Follow-Up Visit (or Early Withdrawal Visit as applicable) to complete the study.

The end of the study will be the date of the last study visit for the last participant in the study (LPLV).

It is planned to include 10 eligible participants into Part 1 of the study to receive AX-8 ODTs administered orally which will be dissolved on the tongue (oromucosal route of administration). Participants will receive doses of AX-8 ODTs up to 80 mg/day, administered split over 2 dosing time points (i.e. 0 hour and + 8 hours), as follows:

Treatment Period 1: 2 x 5 mg tablets, 10 mg total;
Treatment Period 2: 2 x 10 mg tablets, 20 mg total;
Treatment Period 3: 2 x 20 mg tablets, 40 mg total;
Treatment Period 4: 2 x 40 mg tablets, 80 mg total.

Dosing in each sequential treatment period will be staggered; after the first 2 participants (i.e. sentinel group) are dosed there will be at least a 24-hour observation period from the morning dose (0 hour) before the remaining 8 participants are dosed. The remaining participants will be dosed if the sentinel group shows no clinically significant safety or tolerability concerns (including available safety electrocardiograms [ECGs], vital signs measurements, physical examinations and review of any adverse events [AEs]) at the discretion of the PI. Any clinically significant findings from the sentinel group in the opinion of the PI will be discussed with the Sponsor prior to dosing of the remaining 8 participants.

Dose escalation will be based on safety and tolerability data from each treatment period. In addition, available PK data from Treatment Period 1 (5 mg; twice daily) and Treatment Period 2 (10 mg; twice daily) will be used to support dose escalation decisions for Treatment Period 3 (20 mg; twice daily) and Treatment Period 4 (40 mg; twice daily).

Escalation to the next higher dose level (i.e. next sequential treatment period) will not take place until the site's PI and the Sponsor have determined that adequate safety and tolerability data from the previous treatment period has been demonstrated to permit proceeding to the next sequential treatment period (i.e. higher dose level). The minimum data package required for dose escalation decisions will include safety and tolerability data through Day 2 in a minimum of 6 participants (including available safety ECGs, vital signs measurements, physical examinations, clinical laboratory tests and review of any adverse events). Safety reports will be produced summarizing the safety data of the participants. The justification for selection of the dose will be prepared by the investigator for the proposed dose escalation and documented in the dose escalation meeting minutes.

Additional participants may be enrolled if it is deemed appropriate by the site's PI and the Sponsor to repeat a dose level or to study an intermediate dose level (lower than those planned). Repetition of a dose level will not be permitted for dose levels that met any of the stopping rules.

Part 2

The first part of the study (Part 1) has been completed, i.e. 10 participants were recruited and received AX-8 (10 mg to 80 mg/day) over 4 treatment periods (in a dose escalation regimen) and have attended their follow-up visits. The interim analysis of the study data from Part 1 has concluded that tablet dissolution time was too long, affecting systemic exposure to AX-8, probably due to the instructions for administration. Consequently, it was decided to re-evaluate the 5 mg and 40 mg AX-8 tablets with other administration instructions.

It is planned that 10 participants will be enrolled into Part 2 of the study to receive a total dose of 45 mg split into two doses on Day 1 (Dose 1 (5 mg): +0 h, Dose 2 (40 mg): + 8 h).

Part 2 will consist of a Screening Period (Days -28 to -1) to assess eligibility to participate in the study, 1 Treatment Period (Day 1 to Day 2; one overnight stay) and a Follow-Up Visit 7 to 14 days post last dose. There will be no dose escalation decisions nor dose staggering of participants as the doses to be administered in Part 2 are lower than the highest dose level administered in Part 1.

For Part 1 and Part 2; blood samples will be taken pre and post each dose to measure plasma concentrations of AX-8, despropyl AX-8 (metabolite C, MetC) and potentially other AX-8 metabolites and compounds. Subjective assessments to characterise the sensory attributes of the AX-8 ODTs (e.g. feeling factors and taste) will be performed pre and post each dose. Safety assessments will be performed throughout the study and will include monitoring adverse events (AEs), physical examinations, vital signs, 12-lead ECGs, and clinical laboratory tests.

The duration of the study will be approximately 65 days for subjects enrolled in Part 1 and approximately 44 days for subjects enrolled in Part 2; however, the actual duration will depend on the length of the screening period and the washout periods (as appropriate).

Conditions: Healthy
Being tested: AX-8 Part 1, AX-8 Part 2
Keywords: open-label, phase 1, safety, tolerability, pharmacokinetics, healthy volunteers, AX-8

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AX-8 Part 1Drug
5, 10, 20, and 40 mg AX-8 orally disintegrating tablets (ODTs), up to 80 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved on the back of the tongue while the subject is in a sitting position. The subjects will be instructed not to suck, chew or swallow the tablet, i.e. to allow it to dissolve on the back of the tongue without any further intervention.
AX-8 Part 2Drug
5 and 40 mg AX-8 orally disintegrating tablets (ODTs), 45 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved in the mouth while the subject is in a sitting position. The subjects will be instructed to actively move the tablet around in their mouth (i.e. active oral manipulation of the tablet) until it is fully dissolved.

Study groups in NCT04107441
Study group	Role	What they receive
Part 1 arm	Experimental	Ten healthy participants will receive one orally disintegrating tablet (ODT) with 5 mg, 10 mg, 20 mg or 40 mg AX-8 twice daily (8 hours apart, i.e. at 0 hour and +8 hours), during the treatment day (Day 1) of treatment periods 1, 2, 3 or 4, respectively. Receives: Drug: AX-8 Part 1
Part 2 arm	Experimental	Ten healthy participants will receive one orally disintegrating tablet (ODT) with 5 mg AX-8 and one ODT with 40 mg AX-8 8 hours later (i.e. at 0 hour and +8 hours), during the treatment day (Day 1) of the treatment period. Receives: Drug: AX-8 Part 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Monitoring and recording of AEs will be performed throughout the study.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Total protein (g/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Albumin (g/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Total bilirubin (μmol/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Alanine transaminase (ALT, IU/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Aspartate transaminase (AST, IU/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Alkaline phosphatase (IU/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Gamma glutamyl transferase (GGT, IU/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Glucose (mmol/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days
Changes in biochemistry parameters - Sodium (mmol/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Potassium (mmol/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in biochemistry parameters - Creatinine (μmol/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days
Changes in biochemistry parameters - Urea (mmol/L)
Quantified in participants' plasma.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Hemoglobin (g/L)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Hematocrit (HTC, %)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days
Changes in hematology parameters - Mean cell volume (MCV, fL)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Mean cell hemoglobin (pg)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Mean cell hemoglobin concentration (g/dL)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Platelets (10^9/L)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Red blood cell count (10^12/L)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - White blood cell count (10^9/L)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Absolute neutrophils (10^9/L)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Absolute lymphocytes (10^9/L)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Absolute monocytes (10^9/L)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Absolute eosinophils (10^9/L)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Absolute basophils (10^9/L)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Percentage neutrophils (%)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Percentage lymphocytes (%)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Percentage monocytes (%)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Percentage eosinophils (%)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in hematology parameters - Percentage basophils (%)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in coagulation parameters - Prothrombin time (PTT, sec)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in coagulation parameters - International normalized ratio (INR)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in coagulation parameters - Activated partial thromboplastin time (aPTT, sec)
Quantified in participant's whole blood.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Protein (positive or negative)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Glucose (positive or negative)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Specific gravity
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Ketones (positive or negative)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Urobilinogen (normal or abnormal)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Bilirubin (positive or negative)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - pH
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Nitrite (positive or negative)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Leukocytes (positive or negative)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Blood (positive or negative)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - White blood cells (per high power field, HPF)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Red blood cells (HPF)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Bacteria (organisms, HPF)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Hyaline casts (HPF)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Granular casts (HPF)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Cellular casts (HPF)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Epithelial cells (HPF)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Crystals (HPF)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in vital sign parameters - Body mass index (BMI, kg/m^2)
Weight (kg) and height (m) will be combined to report BMI in kg/m^2.
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in vital sign parameters - Pulse rate (beats/min)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in vital sign parameters - Systolic blood pressure (mmHg)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in vital sign parameters - Diastolic blood pressure (mmHg)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in vital sign parameters - Tympanic temperature (°C)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - Heart rate (beats/min)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - RR interval (msec)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - PR interval (msec)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - QRS interval (msec)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - QT interval (msec)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - QTcF interval (msec)
Measured: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.

Secondary outcomes (22)

Area under the plasma concentration-time curve from the first time point [t=0] to the time point of the last measured concentration [tlast] (AUC0-tlast) of AX-8 and its metabolite (ng.h/mL)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Maximum plasma concentration (Cmax) of AX-8 and its metabolite (ng/mL) for Dose 1 (Cmax1) and Dose 2 (Cmax2)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Percentage area extrapolated to infinity (%AUCx) of AX-8 and its metabolite (ng.h/mL)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Residual area, extrapolated area expressed as fraction of AUC(0-∞) (AUC(t-∞)) of AX-8 and its metabolite (ng.h/mL)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Time of maximum plasma concentration (tmax) of AX-8 and its metabolite for Dose 1 (tmax1) and Dose 2 (tmax2) (h)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Elimination half-life (t½) of AX-8 and its metabolite for Dose 2 only (h)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Elimination rate constant (λz) of AX-8 and its metabolite for Dose 2 only (1/h)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Dose normalized AUC0-tlast: AUC0-tlast / (Dose 1 + Dose 2) of AX-8 and its metabolite (ng.h/mL/mg)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Area under the plasma concentration-time curve from the first time point to the 6th hour (AUC0-6) of AX-8 and its metabolite (ng.h/mL)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Area under the plasma concentration-time curve from the 8th to 14th hour (AUC8-14) of AX-8 and its metabolite (ng.h/mL)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Area under the plasma concentration-time curve from the first time point to the 24th hour (AUC0-24) of AX-8 and its metabolite (ng.h/mL)
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Accumulation based on AUC (RAUC): AUC0-6 / AUC8-14 of AX-8 and its metabolite
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Accumulation based on Cmax (RCmax): Cmax2 / Cmax1 of AX-8 and its metabolite
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Dose normalized Cmax: Cmax1 / Dose 1 of AX-8 and its metabolite
Measured: Part 1 and Part 2: Treatment periods (Days 1 and 2).
AX-8 ODT cooling VAS (mm)
Intensity of cooling scored with a 100-mm visual analog scale (VAS) as part of a cooling questionnaire.
Measured: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Sweet taste (mm)
Intensity of sweet taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.
Measured: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Sour taste (mm)
Intensity of sour taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.
Measured: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Salty taste (mm)
Intensity of salty taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.
Measured: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Bitter taste (mm)
Intensity of bitter taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.
Measured: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Umami taste (mm)
Intensity of umami taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.
Measured: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Other taste (mm)
Intensity and nature of other taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.
Measured: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Palatability (mm)
Palatability of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.
Measured: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 20194 Mar 2020

First posted27 Sep 2019
Study start9 Sep 2019
Primary completion25 Feb 2020
Study completion4 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: A first group of 10 participants will be enrolled in the Part 1 of the study (arm 1). Based on the results of Part 1, a second group of 10 participants will be enrolled in Part 2 of the study (arm 2).
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04107441
Sponsor's protocol ID: AX8-002
Other IDs: 2019-002294-57, 2019
Status last verified: Apr 2020
First submitted: 19 Sep 2019
Last updated: 30 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Twice Daily Administration of AX-8 Tablets in Healthy Volunteers in a Single-Centre
ClinicalTrials.gov ID: NCT04107441
Acronym / sponsor ID: AX8-002
Conditions: Healthy
Keywords: open-label, phase 1, safety, tolerability, pharmacokinetics, healthy volunteers, AX-8
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Axalbion SAIndustry (pharma, biotech, devices)
Study start: 9 Sep 2019 (actual)
Primary completion: 25 Feb 2020 (actual)
Study completion: 4 Mar 2020 (actual)
First posted: 27 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose of the study is to see how safe the study drug AX-8 is and how well it is tolerated when administered at different dose levels in healthy participants.

The study will also investigate pharmacokinetics (PK), i.e how the study drug is taken up, metabolized (broken down) and eliminated.

Detailed description

The study consists of two parts.

Part 1

The end of the study will be the date of the last study visit for the last participant in the study (LPLV).

Treatment Period 1: 2 x 5 mg tablets, 10 mg total;
Treatment Period 2: 2 x 10 mg tablets, 20 mg total;
Treatment Period 3: 2 x 20 mg tablets, 40 mg total;
Treatment Period 4: 2 x 40 mg tablets, 80 mg total.

Part 2

It is planned that 10 participants will be enrolled into Part 2 of the study to receive a total dose of 45 mg split into two doses on Day 1 (Dose 1 (5 mg): +0 h, Dose 2 (40 mg): + 8 h).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: A first group of 10 participants will be enrolled in the Part 1 of the study (arm 1). Based on the results of Part 1, a second group of 10 participants will be enrolled in Part 2 of the study (arm 2).

Arm	Type	Receives
Part 1 arm	Experimental	Drug: AX-8 Part 1Ten healthy participants will receive one orally disintegrating tablet (ODT) with 5 mg, 10 mg, 20 mg or 40 mg AX-8 twice daily (8 hours apart, i.e. at 0 hour and +8 hours), during the treatment day (Day 1) of treatment periods 1, 2, 3 or 4, respectively.
Part 2 arm	Experimental	Drug: AX-8 Part 2Ten healthy participants will receive one orally disintegrating tablet (ODT) with 5 mg AX-8 and one ODT with 40 mg AX-8 8 hours later (i.e. at 0 hour and +8 hours), during the treatment day (Day 1) of the treatment period.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy male and female volunteers aged ≥ 18 and ≤ 55 years at the time of informed consent
Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method
Female subjects (regardless of childbearing potential) must agree not to donate ova/oocytes during the study from the first dosing day and until 30 days after the last dose
Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success, or use highly effective contraception together with their female partner(s)
Male subjects must agree not to donate sperm during the study from the first dosing day and until 90 days after last dose

Key exclusion criteria (17 listed)

Prior treatment with AX-8
Hypersensitivity or intolerance to transient receptor potential melastatin subfamily, member 8 (TRPM8) agonists (e.g. menthol, menthol-derivatives, eucalyptol) or any of the excipients of the AX-8 tablets
Current smoker or individuals who have given up smoking for less than 12 months or ex smoker with > 10 pack-years
History of upper or lower respiratory tract infection within 4 weeks prior to screening or prior to first dose.
Requiring concomitant therapy with prohibited medications

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AX-8 Part 15, 10, 20, and 40 mg AX-8 orally disintegrating tablets (ODTs), up to 80 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved on the back of the tongue while the subject is in a sitting position. The subjects will be instructed not to suck, chew or swallow the tablet, i.e. to allow it to dissolve on the back of the tongue without any further intervention.	Drug	Part 1 arm
AX-8 Part 25 and 40 mg AX-8 orally disintegrating tablets (ODTs), 45 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved in the mouth while the subject is in a sitting position. The subjects will be instructed to actively move the tablet around in their mouth (i.e. active oral manipulation of the tablet) until it is fully dissolved.	Drug	Part 2 arm

Primary outcome

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Monitoring and recording of AEs will be performed throughout the study.
Changes in biochemistry parameters - Total protein (g/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in biochemistry parameters - Albumin (g/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in biochemistry parameters - Total bilirubin (μmol/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in biochemistry parameters - Alanine transaminase (ALT, IU/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in biochemistry parameters - Aspartate transaminase (AST, IU/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in biochemistry parameters - Alkaline phosphatase (IU/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in biochemistry parameters - Gamma glutamyl transferase (GGT, IU/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in biochemistry parameters - Glucose (mmol/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days
Quantified in participants' plasma.
Changes in biochemistry parameters - Sodium (mmol/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in biochemistry parameters - Potassium (mmol/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in biochemistry parameters - Creatinine (μmol/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days
Quantified in participants' plasma.
Changes in biochemistry parameters - Urea (mmol/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participants' plasma.
Changes in hematology parameters - Hemoglobin (g/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Hematocrit (HTC, %)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days
Quantified in participant's whole blood.
Changes in hematology parameters - Mean cell volume (MCV, fL)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Mean cell hemoglobin (pg)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Mean cell hemoglobin concentration (g/dL)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Platelets (10^9/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Red blood cell count (10^12/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - White blood cell count (10^9/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Absolute neutrophils (10^9/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Absolute lymphocytes (10^9/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Absolute monocytes (10^9/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Absolute eosinophils (10^9/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Absolute basophils (10^9/L)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Percentage neutrophils (%)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Percentage lymphocytes (%)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Percentage monocytes (%)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Percentage eosinophils (%)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in hematology parameters - Percentage basophils (%)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in coagulation parameters - Prothrombin time (PTT, sec)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in coagulation parameters - International normalized ratio (INR)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in coagulation parameters - Activated partial thromboplastin time (aPTT, sec)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Quantified in participant's whole blood.
Changes in urinalysis parameters - Protein (positive or negative)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Glucose (positive or negative)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Specific gravity
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Ketones (positive or negative)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Urobilinogen (normal or abnormal)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Bilirubin (positive or negative)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - pH
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Nitrite (positive or negative)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Leukocytes (positive or negative)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Blood (positive or negative)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - White blood cells (per high power field, HPF)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Red blood cells (HPF)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Bacteria (organisms, HPF)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Hyaline casts (HPF)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Granular casts (HPF)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Cellular casts (HPF)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Epithelial cells (HPF)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in urinalysis parameters - Crystals (HPF)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in vital sign parameters - Body mass index (BMI, kg/m^2)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Weight (kg) and height (m) will be combined to report BMI in kg/m^2.
Changes in vital sign parameters - Pulse rate (beats/min)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in vital sign parameters - Systolic blood pressure (mmHg)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in vital sign parameters - Diastolic blood pressure (mmHg)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in vital sign parameters - Tympanic temperature (°C)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - Heart rate (beats/min)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - RR interval (msec)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - PR interval (msec)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - QRS interval (msec)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - QT interval (msec)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.
Changes in 12-lead electrocardiogram (ECG) parameters - QTcF interval (msec)
Time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.

22 secondary outcomes

Area under the plasma concentration-time curve from the first time point [t=0] to the time point of the last measured concentration [tlast] (AUC0-tlast) of AX-8 and its metabolite (ng.h/mL)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Maximum plasma concentration (Cmax) of AX-8 and its metabolite (ng/mL) for Dose 1 (Cmax1) and Dose 2 (Cmax2)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Percentage area extrapolated to infinity (%AUCx) of AX-8 and its metabolite (ng.h/mL)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Residual area, extrapolated area expressed as fraction of AUC(0-∞) (AUC(t-∞)) of AX-8 and its metabolite (ng.h/mL)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Time of maximum plasma concentration (tmax) of AX-8 and its metabolite for Dose 1 (tmax1) and Dose 2 (tmax2) (h)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Elimination half-life (t½) of AX-8 and its metabolite for Dose 2 only (h)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Elimination rate constant (λz) of AX-8 and its metabolite for Dose 2 only (1/h)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Dose normalized AUC0-tlast: AUC0-tlast / (Dose 1 + Dose 2) of AX-8 and its metabolite (ng.h/mL/mg)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Area under the plasma concentration-time curve from the first time point to the 6th hour (AUC0-6) of AX-8 and its metabolite (ng.h/mL)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Area under the plasma concentration-time curve from the 8th to 14th hour (AUC8-14) of AX-8 and its metabolite (ng.h/mL)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Area under the plasma concentration-time curve from the first time point to the 24th hour (AUC0-24) of AX-8 and its metabolite (ng.h/mL)
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Accumulation based on AUC (RAUC): AUC0-6 / AUC8-14 of AX-8 and its metabolite
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Accumulation based on Cmax (RCmax): Cmax2 / Cmax1 of AX-8 and its metabolite
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
Dose normalized Cmax: Cmax1 / Dose 1 of AX-8 and its metabolite
Time frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).
AX-8 ODT cooling VAS (mm)
Time frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Sweet taste (mm)
Time frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Sour taste (mm)
Time frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Salty taste (mm)
Time frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Bitter taste (mm)
Time frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Umami taste (mm)
Time frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Other taste (mm)
Time frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Palatability (mm)
Time frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dave Singh, MD principal investigator

Medicines Evaluation Unit (MEU) Ltd

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AX-8 Part 1 and AX-8 Part 2 in people with Healthy, run by Axalbion SA at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: From screening visit to follow-up/early withdrawal visit, approximately 65 days for Part 1 and 44 days for Part 2.). The study lists 63 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04107441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.