Recruitment

Recruitment Status
Completed
Estimated Enrollment
14

Inclusion Criterias

Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
Negative hepatitis panel and HIV screen;
...
Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
Negative hepatitis panel and HIV screen;
Agree to use effective contraceptive methods as defined by protocol;
Sufficient bowel movements (minimum of 1 per day).

Exclusion Criterias

History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
...
History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
Tobacco or nicotine use within 6 months prior to study start;
Exposure to significant radiation within 12 months prior to study start.
Participation in a drug study in which a drug was administered within 30 days prior to study start;
History of alcoholism or drug addiction within 1 year prior to drug administration;
Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;
Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;
Inability or unwillingness to swallow capsules;

Summary

Conditions
Healthy Volunteer
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 55 years
Gender
Only males

Inclusion Criterias

Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
Negative hepatitis panel and HIV screen;
...
Body Mass Index (BMI) 18 to 32 kg/m2, inclusive;
Healthy, as judged by physician from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations;
Negative hepatitis panel and HIV screen;
Agree to use effective contraceptive methods as defined by protocol;
Sufficient bowel movements (minimum of 1 per day).

Exclusion Criterias

History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
...
History of stomach or intestinal surgery or resection except for appendectomy and/or hernia repair;
History or clinical manifestation of: any major medical disorders; any food/drug/substance allergies;
Chronic use of gastric acid inhibitors within 6 months of study start or use of gastric acid inhibitors and/or antacids within 1 month prior to drug administration;
Tobacco or nicotine use within 6 months prior to study start;
Exposure to significant radiation within 12 months prior to study start.
Participation in a drug study in which a drug was administered within 30 days prior to study start;
History of alcoholism or drug addiction within 1 year prior to drug administration;
Evidence of malabsorption syndrome or other condition interfering with gastrointestinal absorption;
Participation in more than one radiolabeled drug study within 12 months preceding drug administration. The previous radiolabeled study drug must have been received more than 6 months prior to this study, and the total exposure from this study and the previous study is less than 5000 mrem whole body annual exposure;
Inability or unwillingness to swallow capsules;

Locations

Madison, Wisconsin, 53704
Madison, Wisconsin, 53704

Tracking Information

NCT #
NCT01967966
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Genentech, Inc.