Clinical trial NCT02205905: An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects
Official title: An Open-label, Single-dose, Non-randomized Study of the Absorption, Metabolism, and Excretion of Intravenously Administered 14C-labeled PER977 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PER977
metabolic disposition
mass balance
metabolites
radiolabeled
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: World Wide Clinical Trials Early Phase Services, LLC
First posted: 2014-08-01
Enrollment: 6
Sex: MALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. Male
2. 18-55 years of age (inclusive)
3. Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)
4. voluntarily consent to participate and provide written informed consent prior to start of study specific procedures
5. Willing and able to remain in the study unit for the entire duration of the confinement period
6. Willing to collect all urine and fecal samples for the duration of the study period as required
7. 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
8. 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
9. 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 Criteria:

1. 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
2. Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory resutls at screening
3. History or presence of allergic or adverse response to anticoagulant reversal agents or related drugs
4. Significantly abnormal diet within 4 weeks
5. Donated blood or plasma within 30 days
6. Participated in another clinical trial (randomized subjects only) within 30 days
7. Participated in a radiolabeled clinical trial within the last 12 months
8. Used any over-the-counter medication, including nutritional supplements, within 7 days
9. Used any prescription medication within 14 days prior
10. 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
11. Smoked or used tobacco products within 60 days
12. History of substance abuse or treatment (including alcohol ) within the past 2 years
13. Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine at screening or check-in
14. 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
15. Has irregular bowel habits
16. Has had significant radiation exposure within the prior 12 months

Primary outcomes:
measure: Mass balance of PER977 and metabolite
timeFrame: 3 weeks
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: 3 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Early Phase Services
state: Texas
Study officials:
affiliation: Worldwide Clinical Trials Early Phase Services
name: Cynthia A Zamora, MD
role: PRINCIPAL_INVESTIGATOR
References: