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

NCT03740217 | Completed Phase 1

• 1 other identifier: GSN000299
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Phase 1

Outcome Measures

Primary Outcomes (2)

• Oral bioavailability (Fz)

  To compare the relative oral bioavailability GKT137831 formulated in capsules or in tablets in healthy male subjects.

  72 hours

• 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 Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  7 days

• Oral bioavailability of GKT138184

  72 hours

• Food effect on oral bioavailability of GKT138184

  72 hours

Study Arms (3)

Treatment A

OTHER

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

Drug: GKT137831

Treatment B:

OTHER

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

Drug: GKT137831

Treatment C

OTHER

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

Drug: GKT137831

Interventions

GKT137831 DRUG

oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Also known as: NOX1/4 inhibitor

Treatment A; Treatment B:; Treatment C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Blood donation (including in the frame of a clinical study) within 2 months before administration;
• General anaesthesia within 3 months before administration;
• Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician;
• Inability to abstain from intensive muscular effort;
• No possibility of contact in case of emergency;
• Any drug intake (except paracetamol) during the last month prior to the first administration;
• History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day);
• Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses / day);
• 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;
• Positive results of screening for drugs of abuse;
• 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;
• Administrative or legal supervision;

Sponsors & Collaborators

• Calliditas Therapeutics AB: lead
• Eurofins Optimed: collaborator
• York Bioanalytical Solution: collaborator

Study Sites (1)

Eurofins Optimed

Gières, 38610, France

Location

MeSH Terms

Interventions

setanaxib

Study Officials

• Yves DONAZZOLO, MD

  Eurofins Optimed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: November 14, 2018
• Study Start: December 19, 2018
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: June 30, 2022

Record last verified: 2019-01

Locations

FR (1)