A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers

Cyclerion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: [14C]-praliciguat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03818295

PRL-105

Details and patient eligibility

About

The primary objective is to characterize the pharmacokinetics (PK) of praliciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-praliciguat.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Healthy Male Volunteers

Experimental group

Description:

Single oral dose of \[14C\]-praliciguat

Treatment:

Drug: [14C]-praliciguat