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

NCT03818295 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-06-19

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

[14C]-praliciguat

10 mg praliciguat containing approximately 500 μCi of \[14C\]-praliciguat

Sponsors & Collaborators

  • Cyclerion Therapeutics

    lead INDUSTRY

Principal Investigators

  • John Hanrahan, MD · Ironwood Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-04-24
Completion
2019-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03818295 on ClinicalTrials.gov