HealthyPhase 1NCT03785054
Phase 1, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of mGlu5 NAM HTL0014242
A Phase 1 study testing HTL0014242 in people with Healthy, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
Trial summary
This is the first time HTL0014242 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when HTL0014242 is administered orally as single doses to healthy subjects. 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?
- HTL0014242
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Nov 2018to 11 Mar 2021
- 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 males or females of any race, between 18 and 55 years of age, inclusive.
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, with a body weight of at least 50.0 kg.
- In good physical and mental health, including no clinically significant findings from medical history, physical examination, psychiatric examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening or check in as assessed by the investigator (or designee).
- Females who are not pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Has clinical laboratory test results within the reference ranges of the testing laboratory, with the exception of results outside the reference ranges that are deemed not clinically significant by the Investigator (or designee) at screening and check-in.
- Has supine blood pressure and pulse rate within the following ranges after 5 minutes rest: systolic blood pressure 90 to 140 mmHg, diastolic blood pressure 40 to 90 mmHg, and pulse rate 45 to 90 bpm.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Who cannot join
- Past or current history of any mental, behavioural, or neurodevelopmental disorder as defined by the tenth revision of the International Classification of Diseases (ICD-10)16 including, but not limited to, diagnoses of: organic, including symptomatic, mental disorders (F00-F09); mental and behavioural disorders due to psychoactive substance use (F10-F19); schizophrenia, schizotypal, and delusional disorders (F20-F29); mood [affective] disorders (F30-F39); neurotic, stress-related, and somatoform disorders (F40-F48); disorders of adult personality and behaviour (F60-F69).
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, gastrointestinal, neurological, respiratory, or endocrine disorder, as determined by the Investigator (or designee).
- Active or history of cardiovascular or cerebrovascular disease, including hypertension, angina, ischaemic heart disease, transient ischaemic attacks, bundle branch block, evidence of myocardial ischaemia, stroke, and peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- Active neoplastic disease or history of any neoplastic disease within 5 years of screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitely treated with standard of care).
- Active infection (eg, sepsis, pneumonia, abscess) or a serious infection (eg, resulting in hospitalisation or requiring parenteral antibiotic treatment) within 6 weeks prior to dosing.
Show all 39Show fewer
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Any of the following at screening and/or predose:
- QT interval corrected for heart rate using Fridericia's method (QTcF) >450 ms confirmed by repeat measurement
- QRS duration >110 ms confirmed by repeat measurement
- PR interval >220 ms confirmed by repeat measurement
- findings which would make QTc measurements difficult or QTc data uninterpretable
- history of additional risk factors for torsades de pointe (eg, heart failure, hypokalemia, family history of long QT syndrome).
- History of alcoholism or drug/chemical abuse.
- Alcohol consumption of >14 units (females) and >21 units (males) per week. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive alcohol breath test result or positive urine drug screen, including cotinine (confirmed by repeat) at screening or check in.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Any of the following haematology values at screening or check-in, as confirmed by 1 repeat if necessary:
- haemoglobin <11 g/dL for females, and <12 g/dL for males
- absolute neutrophil count <1.5 × 109/L (<1500/µL).
- Renal or liver impairment at screening or check-in defined as, confirmed by 1 repeat if necessary:
- serum creatinine ≥135 µmol/L
- ALT and/or AST ≥2 × ULN
- ALP and/or total bilirubin >1.5 × ULN (an isolated total bilirubin >1.5 × ULN is acceptable if total bilirubin is fractionated and direct bilirubin is <35%).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) or medical device within the last 90 days or 5 half-lives of the investigational medication, whichever is longer, prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing.
- Use or intend to use any prescription medications/products within 14 days or 5 half lives of the medication/product, whichever is longer, prior to check-in (hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives are acceptable).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 14 days prior to check in.
- Use or intend to use slow release medications/products considered to still be active within 14 days prior to check in.
- Received live attenuated vaccination within 6 weeks prior to screening or intends to receive such a vaccination during the study.
- Use of tobacco or nicotine containing products (including but not limited to; cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 6 months prior to check-in and the inability to abstain from nicotine-containing products until the follow-up visit.
- Receipt of blood products within 2 months prior to check in.
- Donation of blood (>400 mL) or comparable blood loss (>350 mL) from 3 months prior to screening, plasma donation from 2 weeks prior to screening, or platelets donation from 6 weeks prior to screening.
- Poor peripheral venous access.
- Consumption of caffeine-containing foods and beverages within 72 hours of screening or is unable to abstain from caffeine-containing foods and beverages from 7 days prior to check in until discharge.
- Consumption of any foods or beverages which alter CYP1A2 activity, eg, barbecued food or cruciferous vegetables, such as broccoli and cauliflower, within 14 days prior to check-in (a list of prohibited foods will be provided to subjects).
- Consumption of any foods or beverages containing Seville-type oranges, grapefruit, or poppy seeds within 7 days prior to check-in.
- Have previously completed or withdrawn from this study, and have previously received the IMP.
- Subjects who, in the opinion of the investigator (or designee; including input from subjects' general practitioner, as applicable), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral HTL0014242 in Healthy Adults
This is the first time HTL0014242 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when HTL0014242 is administered orally as single doses to healthy subjects. This information, together with the pharmacokinetics data, will help establish the doses and dosing regimen suitable for future studies in patients
Read the detailed description
This study will comprise a single dose, sequential group design. Overall, up to 72 subjects will be studied in up to 9 planned groups (Groups 1 to 9), with each group consisting of 8 subjects. In addition, a further 6 subjects will participate in a crossover food effect arm.
Subjects will be screened within 28 days prior to dosing. Each subject will participate in 1 treatment period only, except the food effect arm where subjects will be dosed both fed and fasted. Subjects will reside at the clinical research unit from Day -1 (the day before dosing) to Day 5.
All subjects will return for a follow-up visit 7 to 14 days after dosing. The investigator (or designee) may also request that the subject return for an additional follow up visit.
In each of groups 1 to 9, 6 subjects will receive a single dose of HTL0014242 and 2 subjects will receive placebo oral capsule in accordance with a randomisation schedule. In the food effect arm, 6 subjects will receive a single dose of HTL0014242 in both the fed and fasted state, separated by 14 days.
- Conditions
- Healthy
- Being tested
- HTL0014242, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTL0014242Drug
HTL0014242 is a selective negative allosteric modulator (NAM) for the metabotropic glutamate (mGlu) receptor 5 subtype (mGlu5)
Placebo oral capsuleDrug
Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6 subjects receiving a single dose of 1 mg capsule HTL0014242 and 2 subjects receiving matching placebo oral capsule Receives: Drug: HTL0014242; Drug: Placebo oral capsule |
| Cohort 2 | Experimental | 6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. Receives: Drug: HTL0014242; Drug: Placebo oral capsule |
| Cohort 3 | Experimental | 6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. Receives: Drug: HTL0014242; Drug: Placebo oral capsule |
| Cohort 4 | Experimental | 6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. Receives: Drug: HTL0014242; Drug: Placebo oral capsule |
| Cohort 5 | Experimental | 6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. Receives: Drug: HTL0014242; Drug: Placebo oral capsule |
| Cohort 6 | Experimental | 6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. Receives: Drug: HTL0014242; Drug: Placebo oral capsule |
| Cohort 7 | Experimental | 6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. Receives: Drug: HTL0014242; Drug: Placebo oral capsule |
| Cohort 8 | Experimental | 6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. Receives: Drug: HTL0014242; Drug: Placebo oral capsule |
| Cohort 9 | Experimental | 6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. Receives: Drug: HTL0014242; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment related adverse event, including abnormal laboratory events
All AEs, including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations and ECGs will be analyzed in all subjects receiving HTL0014242
Measured: Day -1 to follow up (7-14 days after discharge)
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax)
The observed peak plasma concentration determined from the plasma
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
Area under the curve (AUC) from time 0 to 24 hours postdose (AUC0-24h)
Area under the plasma concentration-time curve up to 24h
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
time to reach the maximum observed plasma concentration (tmax)
time to reach the maximum observed plasma concentration (tmax)
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
Area under the curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast)
Area under the plasma concentration-time curve up to the last measurable timepoint
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-∞)
Area under the curve, calculated as AUC0-tlast + C0-tlast/λz, where C0-tlast is the last observed measurable concentration
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
t1/2 and kel
apparent initial elimination half-life (t1/2) and associated elimination rate onstant (kel)
Measured: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start14 Nov 2018
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Single ascending dose
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nxera Pharma UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MBChB, PhD, Principal investigator, CovanceHamzah Malik, Study director, CovanceRobert Holland, BMBCh, DPhil, Study director, Heptares Therapeutics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785054
- Sponsor's protocol ID
- HTL0014242-101
- Status last verified
- Apr 2021
- First submitted
- 13 Dec 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral HTL0014242 in Healthy Adults
- ClinicalTrials.gov ID
- NCT03785054
- Acronym / sponsor ID
- HTL0014242-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Nxera Pharma UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 24 Dec 2018 (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.
This is the first time HTL0014242 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when HTL0014242 is administered orally as single doses to healthy subjects. This information, together with the pharmacokinetics data, will help establish the doses and dosing regimen suitable for future studies in patients
Detailed description
This study will comprise a single dose, sequential group design. Overall, up to 72 subjects will be studied in up to 9 planned groups (Groups 1 to 9), with each group consisting of 8 subjects. In addition, a further 6 subjects will participate in a crossover food effect arm.
Subjects will be screened within 28 days prior to dosing. Each subject will participate in 1 treatment period only, except the food effect arm where subjects will be dosed both fed and fasted. Subjects will reside at the clinical research unit from Day -1 (the day before dosing) to Day 5.
All subjects will return for a follow-up visit 7 to 14 days after dosing. The investigator (or designee) may also request that the subject return for an additional follow up visit.
In each of groups 1 to 9, 6 subjects will receive a single dose of HTL0014242 and 2 subjects will receive placebo oral capsule in accordance with a randomisation schedule. In the food effect arm, 6 subjects will receive a single dose of HTL0014242 in both the fed and fasted state, separated by 14 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- Model description
- Single ascending dose
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HTL0014242, Drug: Placebo oral capsule6 subjects receiving a single dose of 1 mg capsule HTL0014242 and 2 subjects receiving matching placebo oral capsule |
| Cohort 2 | Experimental | Drug: HTL0014242, Drug: Placebo oral capsule6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. |
| Cohort 3 | Experimental | Drug: HTL0014242, Drug: Placebo oral capsule6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. |
| Cohort 4 | Experimental | Drug: HTL0014242, Drug: Placebo oral capsule6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. |
| Cohort 5 | Experimental | Drug: HTL0014242, Drug: Placebo oral capsule6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. |
| Cohort 6 | Experimental | Drug: HTL0014242, Drug: Placebo oral capsule6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. |
| Cohort 7 | Experimental | Drug: HTL0014242, Drug: Placebo oral capsule6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. |
| Cohort 8 | Experimental | Drug: HTL0014242, Drug: Placebo oral capsule6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. |
| Cohort 9 | Experimental | Drug: HTL0014242, Drug: Placebo oral capsule6 subjects receiving single dose of HTL0014242 and 2 subjects receiving matching placebo oral capsule. The dose of HTL0014242 selected in an escalating manner following review of safety and tolerability data from the previous lower dose level. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy males or females of any race, between 18 and 55 years of age, inclusive.
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, with a body weight of at least 50.0 kg.
- In good physical and mental health, including no clinically significant findings from medical history, physical examination, psychiatric examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening or check in as assessed by the investigator (or designee).
- Females who are not pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Has clinical laboratory test results within the reference ranges of the testing laboratory, with the exception of results outside the reference ranges that are deemed not clinically significant by the Investigator (or designee) at screening and check-in.
Key exclusion criteria (39 listed)
- Past or current history of any mental, behavioural, or neurodevelopmental disorder as defined by the tenth revision of the International Classification of Diseases (ICD-10)16 including, but not limited to, diagnoses of: organic, including symptomatic, mental disorders (F00-F09); mental and behavioural disorders due to psychoactive substance use (F10-F19); schizophrenia, schizotypal, and delusional disorders (F20-F29); mood [affective] disorders (F30-F39); neurotic, stress-related, and somatoform disorders (F40-F48); disorders of adult personality and behaviour (F60-F69).
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, gastrointestinal, neurological, respiratory, or endocrine disorder, as determined by the Investigator (or designee).
- Active or history of cardiovascular or cerebrovascular disease, including hypertension, angina, ischaemic heart disease, transient ischaemic attacks, bundle branch block, evidence of myocardial ischaemia, stroke, and peripheral arterial disease sufficient to cause symptoms and/or require therapy to maintain stable status.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- Active neoplastic disease or history of any neoplastic disease within 5 years of screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitely treated with standard of care).
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 |
|---|---|---|
| HTL0014242HTL0014242 is a selective negative allosteric modulator (NAM) for the metabotropic glutamate (mGlu) receptor 5 subtype (mGlu5) | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
| Placebo oral capsulePlacebo treatment | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
Number of treatment related adverse event, including abnormal laboratory events
Time frame: Day -1 to follow up (7-14 days after discharge)
All AEs, including clinical laboratory, vitals signs, body temperature, respiratory rate, physical examinations and ECGs will be analyzed in all subjects receiving HTL0014242
6 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
Area under the curve (AUC) from time 0 to 24 hours postdose (AUC0-24h)
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
time to reach the maximum observed plasma concentration (tmax)
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
Area under the curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast)
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-∞)
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
t1/2 and kel
Time frame: predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose
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 29 Apr 2021.
- 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.
Jim Bush, MBChB, PhD principal investigator
Covance
Hamzah Malik study director
Covance
Robert Holland, BMBCh, DPhil study director
Heptares Therapeutics 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 HTL0014242 in people with Healthy, run by Nxera Pharma UK Limited 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 7 inclusion and 39 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 29 Apr 2021. 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?
Number of treatment related adverse event, including abnormal laboratory events (time frame: Day -1 to follow up (7-14 days after discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2021.