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

Phase 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740217
• Other study ID #: GSN000299
• Status: Completed
• Phase: Phase 1
• Start date: December 19, 2018
• Est. completion date: February 6, 2019

Study information

• Verified date: January 2019
• Source: Calliditas Therapeutics AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Phase 1

Intervention

Drug:
• GKT137831
oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Locations

Country	Name	City	State
France	Eurofins Optimed	Gières

Sponsors (3)

Lead Sponsor	Collaborator
Calliditas Therapeutics AB	Eurofins Optimed, York Bioanalytical Solution

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral bioavailability (Fz)	To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects.	72 hours
Primary	Food effect on Oral bioavailability (Fz)	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.	72 hours
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	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.	7 days
Secondary	Oral bioavailability of GKT138184	To compare the relative oral bioavailability GKT138184 after oral administration of GKT137831 formulated in capsules or in tablets in healthy male subjects.	72 hours
Secondary	Food effect on oral bioavailability of GKT138184	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.	72 hours