An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects

NCT02205905 | Completed Phase 1 DMC

• 1 other identifier: PER977-01-004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy

Keywords

PER977; metabolic disposition; mass balance; metabolites; radiolabeled

Outcome Measures

Primary Outcomes (1)

• Mass balance of PER977 and metabolite

  To characterize the mass balance, metbaolic 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 to healthy male subjects

  3 weeks

Secondary Outcomes (1)

• Number of subjects with adverse events

  3 weeks

Study Arms (1)

14C PER977

EXPERIMENTAL

Open-label, single-dose, non-randomized study of 14C PER977 in six healthy male subjects

Drug: 14C PER977

Interventions

14C PER977 DRUG

Open-label, single dose

Also known as: ciraprantag

14C PER977

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.: lead
• World Wide Clinical Trials Early Phase Services, LLC: collaborator

Study Sites (1)

Worldwide Clinical Trials Early Phase Services

San Antonio, Texas, 78217, United States

Location

Study Officials

• Cynthia A Zamora, MD

  Worldwide Clinical Trials Early Phase Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: August 1, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 20, 2020

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)