Recruitment

Recruitment Status
Completed

Inclusion Criteria

Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)
Male
voluntarily consent to participate and provide written informed consent prior to start of study specific procedures
...
Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)
Male
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
Willing to collect all urine and fecal samples for the duration of the study period as required
18-55 years of age (inclusive)
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

Exclusion Criteria

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

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)
Male
voluntarily consent to participate and provide written informed consent prior to start of study specific procedures
...
Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)
Male
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
Willing to collect all urine and fecal samples for the duration of the study period as required
18-55 years of age (inclusive)
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

Exclusion Criteria

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

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