A Pharmacokinetic Study of [14C]-GDC-0810 After Single Oral Administration in Healthy Female Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/17/2016 |
| Start Date: | May 2016 |
| End Date: | June 2016 |
This is an open-label, non-randomized study to determine the excretion kinetics and mass
balance of GDC-0810, and to determine metabolites present in blood, feces, and urine in
healthy participants following a single 300-milligram (mg) oral dose of GDC-0810 containing
approximately 100 microcuries of [14C] labeled GDC-0810 using conventional absorption,
metabolism, and excretion (AME) methodology. The entire duration of the study is up to
approximately 8 weeks.
balance of GDC-0810, and to determine metabolites present in blood, feces, and urine in
healthy participants following a single 300-milligram (mg) oral dose of GDC-0810 containing
approximately 100 microcuries of [14C] labeled GDC-0810 using conventional absorption,
metabolism, and excretion (AME) methodology. The entire duration of the study is up to
approximately 8 weeks.
Inclusion Criteria:
- Healthy participants with non-child bearing potential, non-pregnant, non-lactating
and either post-menopausal or surgically sterile.
- Negative pregnancy test result at Screening and at Day -1.
- Body mass index of 18.5 to 29.9 kilogram per square meter.
- Healthy condition documented with no clinically significant findings from laboratory
evaluations, medical history, 12-lead electrocardiograms, and vital signs.
Exclusion Criteria:
- Significant history of metabolic, allergic, dermatological, hepatic, renal,
hematological, pulmonary, cardiovascular, gastric, neurological, or psychiatric
disorder.
- History of significant hypersensitivity or allergy to any drug.
- Uncontrolled hypothyroidism.
- History or presence of clinically significant abnormal electrocardiogram.
- History of venous thrombosis, endometrial disorders, thrombophilic condition,
inflammatory bowel disease, chronic diarrhoea, active or latent tuberculosis, and
Gilbert's syndrome.
- Major surgical procedure or significant traumatic injury within 3 months prior to
study participation.
- Participation in more than one other radiolabeled investigational drug study within
12 months prior to Check-in (Day -1).
- Exposure to significant radiation occuring within 12 months prior to Check-in (Day
-1).
- Any acute or chronic condition that would limit the participant's ability to
participate in the clinical study.
- Failure to satisfy the Investigator of fitness to participate for any other reason.
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