A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers
NCT ID: NCT03818295
Last Updated: 2019-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2019-03-01
2019-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Healthy Male Volunteers
Single oral dose of \[14C\]-praliciguat
[14C]-praliciguat
10 mg praliciguat containing approximately 500 μCi of \[14C\]-praliciguat
Interventions
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[14C]-praliciguat
10 mg praliciguat containing approximately 500 μCi of \[14C\]-praliciguat
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Use of any prescribed or non-prescribed medication
18 Years
55 Years
MALE
Yes
Sponsors
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Cyclerion Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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John Hanrahan, MD
Role: STUDY_DIRECTOR
Ironwood Pharmaceuticals, Inc.
Locations
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Covance Clinical Research Unit Inc.
Madison, Wisconsin, United States
Countries
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Other Identifiers
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PRL-105
Identifier Type: -
Identifier Source: org_study_id
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