Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2019-02-06

Brief Summary

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The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets.

This will be a randomized three-way open cross-over study.

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Detailed Description

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Conditions

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Phase 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subject will be randomly allocated with different formulations of treatment or conditions (Fasting or Fed) during three periods (P1, P2 and P3).

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment A

Single oral dose of 400 mg GKT137831 administered as 4 x 100 mg capsules in fasting conditions.

Group Type OTHER

GKT137831

Intervention Type DRUG

oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Treatment B:

Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fasting conditions.

Group Type OTHER

GKT137831

Intervention Type DRUG

oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Treatment C

Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fed conditions.

Group Type OTHER

GKT137831

Intervention Type DRUG

oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Interventions

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GKT137831

oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Intervention Type DRUG

Other Intervention Names

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NOX1/4 inhibitor

Eligibility Criteria

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Inclusion Criteria

1. Healthy male subject, aged 18 to 60 years inclusive;
2. Non-smoker subject or smoker of not more than 5 cigarettes a day ;
3. No history of alcohol or drug abuse
4. Body Mass Index (BMI) between 18 and 27 5 kg/m2 inclusive;
5. Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination);
6. Signing a written informed consent prior to selection;

Exclusion Criteria

1. Blood donation (including in the frame of a clinical study) within 2 months before administration;
2. General anaesthesia within 3 months before administration;
3. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
4. Inability to abstain from intensive muscular effort;
5. No possibility of contact in case of emergency;
6. Any drug intake (except paracetamol) during the last month prior to the first administration;
7. History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day);
8. Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses / day);
9. Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
10. Positive results of screening for drugs of abuse;
11. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
12. Exclusion period of a previous study;
13. Administrative or legal supervision;

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes