Status:
COMPLETED
An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects
Lead Sponsor:
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Collaborating Sponsors:
World Wide Clinical Trials Early Phase Services, LLC
Conditions:
Healthy
Eligibility:
MALE
15-55 years
Phase:
PHASE1
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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
- Willing and able to remain in the study unit for the entire duration of the confinement period
- Willing to collect all urine and fecal samples for the duration of the study period as required
- Will to eat entire meals and snacks provided during confinement at the research facility, and understand diet will include foods with high fiber content and possibly prune juice
- Willing to use a waterless commode located in a designated dry room for urine and feces collection for the duration of the study period as required
- Willing to abstain from showering for the first 72 hours following study drug administration. After the restriction is lifted, willing to provide a urine sample prior to showering for the remainder of the confinement period.
Exclusion
- 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
- Donated blood or plasma within 30 days
- Participated in another clinical trial (randomized subjects only) within 30 days
- Participated in a radiolabeled clinical trial within the last 12 months
- Used any over-the-counter medication, including nutritional supplements, within 7 days
- Used any prescription medication within 14 days prior
- Treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates,phenothiazines, cimetidine, carbamazepine, etc. within 30 days
- Smoked or used tobacco products within 60 days
- History of substance abuse or treatment (including alcohol ) within the past 2 years
- Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine at screening or check-in
- Positive test for hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus at screening or has previously been treated for hepatitis B, hepatitis C or HIV infection
- Has irregular bowel habits
- Has had significant radiation exposure within the prior 12 months
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02205905
Start Date
July 1 2014
End Date
August 1 2014
Last Update
May 20 2020
Active Locations (1)
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1
Worldwide Clinical Trials Early Phase Services
San Antonio, Texas, United States, 78217