An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- 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
- ...
- 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 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.
- 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
- 18-55 years of age (inclusive)
- 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
- Male
Exclusion Criteria
- Has had significant radiation exposure within the prior 12 months
- Smoked or used tobacco products within 60 days
- Donated blood or plasma within 30 days
- ...
- Has had significant radiation exposure within the prior 12 months
- Smoked or used tobacco products within 60 days
- Donated blood or plasma within 30 days
- Significantly abnormal diet within 4 weeks
- 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
- History or presence of allergic or adverse response to anticoagulant reversal agents or related drugs
- Used any over-the-counter medication, including nutritional supplements, within 7 days
- 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
- Used any prescription medication within 14 days prior
- Participated in a radiolabeled clinical trial within the last 12 months
- Has irregular bowel habits
- 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
- Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory resutls at screening
- Participated in another clinical trial (randomized subjects only) within 30 days
Summary
- Conditions
- Healthy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 15 years and 55 years
- Gender
- Only males
Inclusion Criteria
- 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
- ...
- 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 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.
- 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
- 18-55 years of age (inclusive)
- 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
- Male
Exclusion Criteria
- Has had significant radiation exposure within the prior 12 months
- Smoked or used tobacco products within 60 days
- Donated blood or plasma within 30 days
- ...
- Has had significant radiation exposure within the prior 12 months
- Smoked or used tobacco products within 60 days
- Donated blood or plasma within 30 days
- Significantly abnormal diet within 4 weeks
- 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
- History or presence of allergic or adverse response to anticoagulant reversal agents or related drugs
- Used any over-the-counter medication, including nutritional supplements, within 7 days
- 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
- Used any prescription medication within 14 days prior
- Participated in a radiolabeled clinical trial within the last 12 months
- Has irregular bowel habits
- 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
- Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory resutls at screening
- Participated in another clinical trial (randomized subjects only) within 30 days
Tracking Information
- NCT #
- NCT02205905
- Collaborators
- World Wide Clinical Trials Early Phase Services, LLC
- Investigators
- Principal Investigator: Cynthia A Zamora, MD Worldwide Clinical Trials Early Phase Services
- Cynthia A Zamora, MD Worldwide Clinical Trials Early Phase Services
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