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

Phase 1

Completed

• Conditions: Phase 1
• Interventions: Drug: GKT137831

• Registration Number: NCT03740217
• Lead Sponsor: Calliditas Therapeutics AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Study Start: 2018-12-19
• Status Verified: 2019-01
• Primary Completion: 2019-02-06
• Study Completion: 2019-02-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	GKT137831	Single oral dose of 400 mg GKT137831 administered as 4 x 100 mg capsules in fasting conditions.
Treatment B:	GKT137831	Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fasting conditions.
Treatment C	GKT137831	Single oral dose of 400 mg GKT137831 administered as 1 x 400 mg tablets in fed conditions.

Primary Outcome Measures

Name	Time	Method
Oral bioavailability (Fz)	72 hours	To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects.
Food effect on Oral bioavailability (Fz)	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

Name	Time	Method
Food effect on oral bioavailability of GKT138184	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.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	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.
Oral bioavailability of GKT138184	72 hours	To compare the relative oral bioavailability GKT138184 after oral administration of GKT137831 formulated in capsules or in tablets in healthy male subjects.

Trial Locations

Locations (1)

Eurofins Optimed; 🇫🇷 Gières, France