A Pharmacokinetic Study of [14C]-GDC-0810 After Single Oral Administration in Healthy Female Participants

Genentech

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: [14C]-GDC-0810

Study type

Interventional

Funder types

Industry

Identifiers

NCT02802670

GP29916

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.