A Pharmacokinetic Study of [14C]-GDC-0810 After Single Oral Administration in Healthy Female Participants
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT02802670
- Run by
- Genentech, Inc.
- People needed
- 7
- Starts
- 2016-05-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-06-16
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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