Trial | NCT03795519  Report issue

Title

A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Olinciguat ([14C]-IW-1701) Following a Single Oral Dose in Healthy Male Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    8
The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-olinciguat.
OLI-103 is a Phase 1 open-label, nonrandomized, single-dose study in up to 8 subjects that will be conducted at a single center in the US. Safety assessments will be performed throughout the clinic period and multiple PK samples will be collected. Subjects will be confined to the clinical research center for at least 8 days.

The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-olinciguat and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces after a single oral dose. The study will help identify and characterize olinciguat metabolites, evaluate the likelihood of effects of liver or kidney impairment on the disposition of olinciguat, and assess the likelihood of drug-drug interactions with olinciguat.
Study Started
Jan 17
2019
Primary Completion
Feb 27
2019
Study Completion
Feb 27
2019
Last Update
Apr 03
2019

Drug [14C]-olinciguat

oral capsule

  • Other names: 14C-IW-1701

Healthy Male Volunteers Experimental

Single oral dose of [14C]-olinciguat

Criteria 

Inclusion Criteria:

Males of any race, between 18 and 55 years of age, inclusive
Body mass index between 18 and 32 kg/m2, inclusive
Subject is in good health and has no clinically significant findings on physical examination
Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 90 days after the final dose of study drug

Exclusion Criteria:

Any active or unstable clinically significant medical condition
Use of any prescribed or non-prescribed medication

Additional inclusion/exclusion criteria may apply per protocol
No Results Posted