Completed
An Open-label, Single-dose, Non-randomized Study of the Absorption, Metabolism, and Excretion of Intravenously Administered 14C-labeled PER977 in Healthy Male Subjects
What is being tested
14C PER977
Drug
Who is being recruted
From 15 to 55 Years
+25 Eligibility Criteria
How is the trial designed
Basic Science Study
Phase 1
Interventional
Study Start: July 2014
Summary
Principal SponsorPerosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2014
Actual date on which the first participant was enrolled.This is an open-label, single-dose, non-randomized study in healthy male subjects to characterize the mass balance, metabolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.
Official TitleAn Open-label, Single-dose, Non-randomized Study of the Absorption, Metabolism, and Excretion of Intravenously Administered 14C-labeled PER977 in Healthy Male Subjects
Principal SponsorPerosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 15 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
9 inclusion criteria required to participate
Male
18-55 years of age (inclusive)
Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)
voluntarily consent to participate and provide written informed consent prior to start of study specific procedures
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16 exclusion criteria prevent from participating
History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any condition which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results
Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory resutls at screening
History or presence of allergic or adverse response to anticoagulant reversal agents or related drugs
Significantly abnormal diet within 4 weeks
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalOpen-label, single-dose, non-randomized study of 14C PER977 in six healthy male subjects
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Worldwide Clinical Trials Early Phase Services
San Antonio, United StatesOpen Worldwide Clinical Trials Early Phase Services in Google MapsCompletedOne Study Center