Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740217
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
Eurofins Optimed
York Bioanalytical Solution
Information provided by (Responsible Party):
Genkyotex SA

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Phase 1 Drug: GKT137831 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Subject will be randomly allocated with different formulations of treatment or conditions (Fasting or Fed) during three periods (P1, P2 and P3).
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets and Evaluation of the Potential Impact of Concomitant Food Intake on the Relative Bioavailability of GKT137831 in Healthy Male Subjects
Actual Study Start Date : December 19, 2018
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Arm Intervention/treatment
Treatment A
Single oral dose of 400 mg GKT137831 administered as 4 x 100 mg capsules in fasting conditions.
Drug: GKT137831
oral bioavailable small molecule that selectively inhibit NOX1 and NOX4
Other Name: NOX1/4 inhibitor

Treatment B:
Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fasting conditions.
Drug: GKT137831
oral bioavailable small molecule that selectively inhibit NOX1 and NOX4
Other Name: NOX1/4 inhibitor

Treatment C
Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fed conditions.
Drug: GKT137831
oral bioavailable small molecule that selectively inhibit NOX1 and NOX4
Other Name: NOX1/4 inhibitor




Primary Outcome Measures :
  1. Oral bioavailability (Fz) [ Time Frame: 72 hours ]
    To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects.

  2. Food effect on Oral bioavailability (Fz) [ Time Frame: 72 hours ]
    To assess the impact of concomitant food intake on the relative bioavailability of GKT137831 after single oral dose administration of a 400 mg GKT137831 tablet in healthy male subjects.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 7 days ]
    To compare the safety and tolerability of single oral dose administration of 400 mg GKT137831 formulated in capsules or in tablets, and to evaluate the potential impact of concomitant food intake on the safety and tolerability of single oral dose administration of 400 mg GKT137831 tablet in healthy adult male subjects.

  2. Oral bioavailability of GKT138184 [ Time Frame: 72 hours ]
    To compare the relative oral bioavailability GKT138184 after oral administration of GKT137831 formulated in capsules or in tablets in healthy male subjects.

  3. Food effect on oral bioavailability of GKT138184 [ Time Frame: 72 hours ]
    To assess the impact of concomitant food intake on the relative bioavailability of GKT138184 after single oral dose administration of a 400 mg GKT137831 tablet in healthy male subjects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740217


Locations
Layout table for location information
France
Eurofins Optimed
Gières, France, 38610
Sponsors and Collaborators
Genkyotex SA
Eurofins Optimed
York Bioanalytical Solution
Investigators
Layout table for investigator information
Principal Investigator: Yves DONAZZOLO, MD Eurofins Optimed

Layout table for additonal information
Responsible Party: Genkyotex SA
ClinicalTrials.gov Identifier: NCT03740217     History of Changes
Other Study ID Numbers: GSN000299
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No