A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/3/2016 |
| Start Date: | September 2012 |
| End Date: | September 2012 |
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0973 Following Single Oral Dose Administration in Healthy Male Subjects
This open-label, non-randomized study will assess the absorption, metabolism, and excretion
of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a
single dose of [14C]-GDC-0973.
of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a
single dose of [14C]-GDC-0973.
Inclusion Criteria:
- Body mass index (BMI) between 18.5 and 29.9 kg/m2, inclusive
- No clinically significant findings from medical history, 12-lead ECG, and vital signs
and laboratory evaluations
- Negative test for selected drugs of abuse
- No infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV)
- Sterile or agree to use an adequate contraception method
- Historically able to produce a minimum of 1 bowel movement per day
Exclusion Criteria:
- Significant history or clinical manifestation of any significant metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug
compound, food, or other substance unless approved by the Investigator
- History of stomach or intestinal surgery or resection (including a cholecystectomy)
that would potentially alter absorption and/or excretion of orally administered drugs
except that appendectomy and/or hernia repair will be allowed
- History of Gilbert's Syndrome
- History of diabetes mellitus and/or elevated fasting glucose at baseline
- History or presence of an abnormal ECG
- History of alcoholism or drug addiction within 1 year prior Check-in
- Participation in more than one other radiolabeled investigational study drug trial
within 12 months prior to Check-in
- Exposure to significant radiation within 12 months prior to Check-in study drug
occurred within 5 half-lives or 30 days, whichever is longer, prior to Check-in
- Use of any tobacco-containing or nicotine-containing products within 6 months prior
to Check-in
- Participation in any other investigational study drug or biologic agent trial in
which receipt of an investigational study drug occurred within 5 half-lives or 30
days, whichever is longer, prior to Check-in
- Use of any prescription medications/products within 14 days prior to Check-in
We found this trial at
1
site
Click here to add this to my saved trials
