Skip to main content
OpenTrials
Completed

NCT Number: NCT03740217

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Eurofins Optimed

Gières, 38610, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;
  • Exclusion period of a previous study;
  • Administrative or legal supervision;

Treatment and study plan

GKT137831

Drug

oral bioavailable small molecule that selectively inhibit NOX1 and NOX4

Other names: NOX1/4 inhibitor

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Calliditas Therapeutics AB

Industry

Collaborators

  • Eurofins Optimed
  • York Bioanalytical Solution

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2018
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.