Chronic Kidney DiseasePhase 1NCT04024501

A Study to Assess the Relative Bioavailability of 3 Different Formulations Under Fasted and Fed Condition

A Phase 1 study testing Verinurad ER8 capsule formulation (fasted), Verinurad A-capsule formulation (fasted) and Verinurad A-capsule formulation (fed) in people with Chronic Kidney Disease, run by AstraZeneca at 1 site in Germany.

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

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Verinurad ER8 capsule formulation (fasted), Verinurad A-capsule formulation (fasted) and Verinurad A-capsule formulation (fed)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteGermany
Study dates: 20 Jul 2019to 18 Sep 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male and female participants aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
Females must have a negative pregnancy test at screening and on admission to the unit and must be:
not pregnant or currently lactating or breastfeeding. (2) of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: (i) postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range (FSH levels > 40 IU/mL).
documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
OR if of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy for the entire study period.

Who cannot join

History of gout or any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of verinurad.
History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator at screening and first admission, including: (1) Alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN), (2) Aspartate aminotransferase (AST) > 1.5 x ULN, (3) Bilirubin (total) > 1.5 x ULN, (4) Gamma glutamyl transpeptidase (GGT) > 1.5 x ULN. (5) If any of these tests are out-of-range, the tests can be repeated once.
Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the Clinical Unit, including, but not limited to, any of the following:
Heart rate (resting, supine) < 50 beats per minute (bpm) or > 85 bpm, (2) Systolic BP < 90 mmHg or > 140 mmHg and/or diastolic BP < 50 mmHg or > 90 mmHg sustained for > 10 min while resting in a supine position.

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6. Any clinically significant abnormalities on 12-lead Electrocardiogram (ECG) at the Screening Visit, including, but not limited to any of the following:
ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for heart rate using Fridericia's formula (QTcF) > 450 ms or < 340 ms or family history of long QT syndrome,
Any significant arrhythmia,
Conduction abnormalities:
Clinically significant PR (PQ) interval prolongation (> 240 ms); intermittent second or third degree atrioventricular (AV) block, or AV dissociation,
Complete bundle branch block and/or QRS duration > 120 ms. 7. Any positive result at the Screening Visit for serum hepatitis B surface antigen or antiHBc antibody, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
8. Suspicion or known Gilbert's and/or Lesch-Nyhan syndrome. 9. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for women.
10. Has received another new chemical entity (defined as a compound which has not been approved for marketing in the US) within 30 days or at least 5 half-lives (whichever is longer) of the first administration of verinurad in this study.
11. Participants who have previously received verinurad. 12. Plasma donation within 1 month of screening or any blood donation/loss of more than 500 mL during the 3 months prior to the Screening Visit.
13. Participants who are pregnant, lactating or planning to become pregnant. 14. History of severe allergy/hypersensitivity or ongoing clinically relevant allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to verinurad.
15. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
16. Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the PI. Excessive intake of caffeine defined as regular consumption of more than 600 mg of caffeine per day (e.g., > 5 cups of coffee) or would likely be unable to refrain from the use of caffeine containing beverages during confinement at the investigational site.
17. Positive screen for drugs of abuse or cotinine (nicotine) at the Screening Visit or positive screen for alcohol, drugs of abuse and cotinine on each admission to the study centre.
18. Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of verinurad.
19. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of verinurad or longer if the medication has a long half-life. The use of hormonal contraception therapy and hormonal replacement therapy for females are permitted.
20. Any AstraZeneca, PAREXEL or study site employee or their close relatives. 21. Participants who cannot communicate reliably with the PI and/or is not able to read, speak and understand the German language.
22. Judgment by the PI that the participant should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
23. Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
24. Participants with any special dietary restrictions such as participants that are lactose intolerant or are vegetarians/vegans.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Research Site
Berlin, 14050

Other trials in Germany

About this study

Official title: A Randomised, Single-dose, 5-period, 5-treatment, Crossover Study to Assess the Relative Bioavailability of 3 Different Extended-release Formulations of Verinurad in Healthy Subjects

This study is intended to assess the relative bioavailability between the (extended-release) ER8 capsule formulation (the formulation that is currently used for verinurad development) given under fasted conditions and 2 new capsule formulations of verinurad (A-capsule and B-capsule) given under fed or fasted conditions. All three capsules target an 8-hour release profile (extended-release). The highest dose (12 mg) currently tested in participants will be tested in this study. The study is designed to provide information to optimize the verinurad part of a fixed dose combination capsule to be used in future development.

Read the detailed description

This study will be a randomised, open-label, single-dose, 5-period, 5-treatment, crossover study in healthy male and female participants, performed at a single study centre. This study is intended to assess the relative bioavailability between the ER8 capsule formulation (the formulation that is currently used for verinurad development) given under fasted conditions and 2 new capsule formulation of verinurad (A-capsule and B-capsule) given under fed or fasted conditions. All three capsules target an 8-hour release profile (extended-release). The highest dose (12 mg) currently tested in participants will be tested in this study. The study is designed to provide information to optimize the verinurad part of a fixed dose combination capsule to be used in future development. The study will comprise: a screening period of maximum 28 days; five treatment periods during which participants will be resident from the morning of the day before dosing with verinurad (Day -1) until at least 72 hours after dosing; discharged on the morning of Day 4 of each Treatment Period; and a follow-up Visit within 7 to 14 days after the last administration of verinurad. There will be a minimum washout period of 5 days between each dose administration. A total of 25 healthy male and female participants will be randomised into this study. Each participant will receive five single-dose treatments of 12 mg verinurad with 240 mL water, following an overnight fast of at least 10 hours. Participants will follow an overnight fast of at least 10 hours before the dosing procedures: for the fed dosing, a high-fat, high-calorie standard breakfast will be served 30 minutes before the planned administration of verinurad to be consumed in full at least 5 minutes before dosing; for the fasted dosing, no breakfast will be served. A meal can be given 4 hours after administration of verinurad for both dosing states. The duration of the study is expected to be approximately 9 weeks for each individual participant (including the 28-day screening period).

Conditions: Chronic Kidney Disease
Being tested: Verinurad ER8 capsule formulation (fasted), Verinurad A-capsule formulation (fasted), Verinurad A-capsule formulation (fed), Verinurad B-capsule formulation (fasted), Verinurad B-capsule formulation (fed)
Keywords: URAT1 inhibitor, Uric acid transporter 1, Verinurad, Crossover study, Relative bioavailability, Pharmacokinetics
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

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

Verinurad ER8 capsule formulation (fasted)Drug
Each participant will receive single-dose treatment of 12 mg verinurad ER8 capsule with 240 mL water, following an overnight fast of at least 10 hours.
Verinurad A-capsule formulation (fasted)Drug
Each participant will receive single-dose treatment of 12 mg verinurad A-capsule with 240 mL water, following an overnight fast of at least 10 hours.
Verinurad A-capsule formulation (fed)Drug
Each participant will receive single dose treatment of 12 mg verinurad A-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast).
Verinurad B-capsule formulation (fasted)Drug
Each participant will receive single-dose treatment of 12 mg verinurad B-capsule with 240 mL water, following an overnight fast of at least 10 hours.
Verinurad B-capsule formulation (fed)Drug
Each participant will receive single dose treatment of 12 mg verinurad B-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast).

Study groups in NCT04024501
Study group	Role	What they receive
Treatment 1	Experimental	During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state. Receives: Drug: Verinurad ER8 capsule formulation (fasted)
Treatment 2	Experimental	During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state. Receives: Drug: Verinurad A-capsule formulation (fasted)
Treatment 3	Experimental	During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state. Receives: Drug: Verinurad A-capsule formulation (fed)
Treatment 4	Experimental	During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state. Receives: Drug: Verinurad B-capsule formulation (fasted)
Treatment 5	Experimental	During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state. Receives: Drug: Verinurad B-capsule formulation (fed)

What is being measured

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

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC)
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose
AUC From Time 0 to the Last Quantifiable Concentration (AUC0-t) for the Analysis of PK Parameter
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose
Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose

Secondary outcomes (9)

AUC From Time 0 to 24 Hours Post Dose (AUC0-24) for the Analysis of PK Parameter
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Measured: Pre-dose and up to 24-hours Post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for the Analysis of PK Parameter
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) for the Analysis of PK Parameter
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for the Analysis of PK Parameter
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose
Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRT) for the Analysis of PK Parameter
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose
Time of Last Quantifiable Plasma Concentration (Tlast) for the Analysis of PK Parameter
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose
Volume of Distribution at Steady State (Intravenous Dosing) (Vss/F) for the Analysis of PK Parameter
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for the Analysis of PK Parameter
To examine the PK profiles of verinurad when administered as the 3 different capsule formulations under fasted conditions.
Measured: Day 1: Pre-dose and up to 72-hour Post-dose
Number of Participants With Adverse Events (AEs)
To assess AEs as variable of safety and tolerability of single doses of verinurad in healthy participants.
Measured: From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)

Timeline

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

20 Jul 201918 Sep 2019

First posted18 Jul 2019
Study start20 Jul 2019
Primary completion18 Sep 2019
Study completion18 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04024501
Sponsor's protocol ID: D5495C00005
Status last verified: Feb 2021
First submitted: 16 Jul 2019
Last updated: 18 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Single-dose, 5-period, 5-treatment, Crossover Study to Assess the Relative Bioavailability of 3 Different Extended-release Formulations of Verinurad in Healthy Subjects
ClinicalTrials.gov ID: NCT04024501
Acronym / sponsor ID: D5495C00005
Conditions: Chronic Kidney Disease
Keywords: URAT1 inhibitor, Uric acid transporter 1, Verinurad, Crossover study, Relative bioavailability, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 20 Jul 2019 (actual)
Primary completion: 18 Sep 2019 (actual)
Study completion: 18 Sep 2019 (actual)
First posted: 18 Jul 2019 (actual)
Results: Posted 21 Aug 2020

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Treatment 1	Experimental	Drug: Verinurad ER8 capsule formulation (fasted)During this treatment period, healthy participants will receive 1 x 12 mg verinurad ER8 capsule formulation in fasted state.
Treatment 2	Experimental	Drug: Verinurad A-capsule formulation (fasted)During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fasted state.
Treatment 3	Experimental	Drug: Verinurad A-capsule formulation (fed)During this treatment period, healthy participants will receive 2 x 6 mg verinurad A-capsule formulation in fed state.
Treatment 4	Experimental	Drug: Verinurad B-capsule formulation (fasted)During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fasted state.
Treatment 5	Experimental	Drug: Verinurad B-capsule formulation (fed)During this treatment period, healthy participants will receive 2 x 6 mg verinurad B-capsule formulation in fed state.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male and female participants aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
Females must have a negative pregnancy test at screening and on admission to the unit and must be:
not pregnant or currently lactating or breastfeeding. (2) of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: (i) postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range (FSH levels > 40 IU/mL).

Key exclusion criteria (25 listed)

History of gout or any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of verinurad.
History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator at screening and first admission, including: (1) Alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN), (2) Aspartate aminotransferase (AST) > 1.5 x ULN, (3) Bilirubin (total) > 1.5 x ULN, (4) Gamma glutamyl transpeptidase (GGT) > 1.5 x ULN. (5) If any of these tests are out-of-range, the tests can be repeated once.
Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the Clinical Unit, including, but not limited to, any of the following:

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
Verinurad ER8 capsule formulation (fasted)Each participant will receive single-dose treatment of 12 mg verinurad ER8 capsule with 240 mL water, following an overnight fast of at least 10 hours.	Drug	Treatment 1
Verinurad A-capsule formulation (fasted)Each participant will receive single-dose treatment of 12 mg verinurad A-capsule with 240 mL water, following an overnight fast of at least 10 hours.	Drug	Treatment 2
Verinurad A-capsule formulation (fed)Each participant will receive single dose treatment of 12 mg verinurad A-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast).	Drug	Treatment 3
Verinurad B-capsule formulation (fasted)Each participant will receive single-dose treatment of 12 mg verinurad B-capsule with 240 mL water, following an overnight fast of at least 10 hours.	Drug	Treatment 4
Verinurad B-capsule formulation (fed)Each participant will receive single dose treatment of 12 mg verinurad B-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast).	Drug	Treatment 5

Primary outcome

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC)
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
AUC From Time 0 to the Last Quantifiable Concentration (AUC0-t) for the Analysis of PK Parameter
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.
Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
To evaluate the relative bioavailability between the A-capsule and B-capsule formulations under both fed and fasted conditions with the ER8 capsule formulation under fasted conditions and with each other under the same food conditions.

9 secondary outcomes

AUC From Time 0 to 24 Hours Post Dose (AUC0-24) for the Analysis of PK Parameter
Time frame: Pre-dose and up to 24-hours Post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for the Analysis of PK Parameter
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) for the Analysis of PK Parameter
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for the Analysis of PK Parameter
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRT) for the Analysis of PK Parameter
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
Time of Last Quantifiable Plasma Concentration (Tlast) for the Analysis of PK Parameter
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
Volume of Distribution at Steady State (Intravenous Dosing) (Vss/F) for the Analysis of PK Parameter
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for the Analysis of PK Parameter
Time frame: Day 1: Pre-dose and up to 72-hour Post-dose
Number of Participants With Adverse Events (AEs)
Time frame: From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose)

Results and safety

Results posted to the registry on 21 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall-All Subjects	25	25

Primary outcome: Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC)

Time frame: Day 1: Pre-dose and up to 72-hour Post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Treatment 1: 1 x 12 mg ER8 Capsule Fasted n = 25	Treatment 2: 2 x 6 mg A-capsule Fasted n = 25	Treatment 3: 2 x 6 mg A-capsule Fed n = 25	Treatment 4: 2 x 6 mg B-capsule Fasted n = 25	Treatment 5: 2 x 6 mg B-capsule Fed n = 25
Value	171.3 (47.60)	167.5 (33.72)	87.14 (65.84)	149.0 (39.78)	150.2 (42.57)

Treatment 1: 1 x 12 mg ER8 Capsule Fasted vs Treatment 2: 2 x 6 mg A-capsule Fasted: Geometric Mean ratio: 106.20 (90% CI 91.73 to 122.96), Mixed Model Analysis
Treatment 1: 1 x 12 mg ER8 Capsule Fasted vs Treatment 3: 2 x 6 mg A-capsule Fed: Geometric mean ratio: 50.02 (90% CI 42.34 to 59.10), Mixed Model Analysis
Treatment 2: 2 x 6 mg A-capsule Fasted vs Treatment 3: 2 x 6 mg A-capsule Fed: Geometric mean ratio: 47.10 (90% CI 39.85 to 55.68), Mixed Model Analysis

Population analysed: The PK analysis set consisted of all subjects in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations thought to impact on the analysis of the PK data.

Primary outcome: AUC From Time 0 to the Last Quantifiable Concentration (AUC0-t) for the Analysis of PK Parameter

Time frame: Day 1: Pre-dose and up to 72-hour Post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Treatment 1: 1 x 12 mg ER8 Capsule Fasted n = 25	Treatment 2: 2 x 6 mg A-capsule Fasted n = 25	Treatment 3: 2 x 6 mg A-capsule Fed n = 25	Treatment 4: 2 x 6 mg B-capsule Fasted n = 25	Treatment 5: 2 x 6 mg B-capsule Fed n = 25
Value	166.8 (47.57)	167.5 (35.96)	67.04 (80.37)	128.5 (49.29)	139.6 (44.36)

Treatment 1: 1 x 12 mg ER8 Capsule Fasted vs Treatment 2: 2 x 6 mg A-capsule Fasted: Geometric mean ratio: 100.39 (90% CI 84.94 to 118.65), Mixed Model Analysis
Treatment 1: 1 x 12 mg ER8 Capsule Fasted vs Treatment 3: 2 x 6 mg A-capsule Fed: Geometric mean ratio: 41.26 (90% CI 34.74 to 49.00), Mixed Model Analysis
Treatment 2: 2 x 6 mg A-capsule Fasted vs Treatment 3: 2 x 6 mg A-capsule Fed: Geometric mean ratio: 41.10 (90% CI 34.61 to 48.81), Mixed Model Analysis

Primary outcome: Maximum Observed Plasma Concentration (Cmax) for the Analysis of PK Parameter

Time frame: Day 1: Pre-dose and up to 72-hour Post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment 1: 1 x 12 mg ER8 Capsule Fasted n = 25	Treatment 2: 2 x 6 mg A-capsule Fasted n = 25	Treatment 3: 2 x 6 mg A-capsule Fed n = 25	Treatment 4: 2 x 6 mg B-capsule Fasted n = 25	Treatment 5: 2 x 6 mg B-capsule Fed n = 25
Value	25.51 (53.66)	31.88 (62.41)	8.243 (81.12)	23.39 (66.08)	17.02 (54.00)

Treatment 1: 1 x 12 mg ER8 Capsule Fasted vs Treatment 2: 2 x 6 mg A-capsule Fasted: Geometric mean ratio: 124.99 (90% CI 101.09 to 154.54), Mixed Model Analysis
Treatment 1: 1 x 12 mg ER8 Capsule Fasted vs Treatment 3: 2 x 6 mg A-capsule Fed: Geometric mean ratio: 33.77 (90% CI 27.15 to 42.01), Mixed Model Analysis
Treatment 2: 2 x 6 mg A-capsule Fasted vs Treatment 3: 2 x 6 mg A-capsule Fed: Geometric mean ratio: 27.02 (90% CI 21.72 to 33.61), Mixed Model Analysis

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening (Day -28 to Day -2) till follow-up visit (7 to 14 days post-final dose). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment 1: 1 x 12 mg ER8 Capsule Fasted	0 of 25 (0%)	5 of 25 (20%)	0 of 25
Treatment 2: 2 x 6 mg A-capsule Fasted	0 of 25 (0%)	6 of 25 (24%)	0 of 25
Treatment 3: 2 x 6 mg A-capsule Fed	0 of 25 (0%)	2 of 25 (8%)	0 of 25
Treatment 4: 2 x 6 mg B-capsule Fasted	0 of 25 (0%)	4 of 25 (16%)	0 of 25
Treatment 5: 2 x 6 mg B-capsule Fed	0 of 25 (0%)	3 of 25 (12%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
redacted CSP and SAPLink provided by the sponsor.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 25 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 18 Mar 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 Germany. 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?

Yes. Results are posted in the registry (first posted 21 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC) (time frame: Day 1: Pre-dose and up to 72-hour Post-dose). The study lists 3 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 NCT04024501.

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 18 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.