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

NCT ID: NCT02802670

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-06-30

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

GDC-0810

GDC-0810 300-mg dose administered as oral solution, containing approximately 100 microcuries of \[14C\]-labeled GDC-0810.

Group Type: EXPERIMENTAL

[14C]-GDC-0810

Intervention Type: DRUG

Participants will receive a single 300-mg dose of GDC-0810 containing approximately 100 microcuries of \[14C\]-labeled GDC-0810 on Day 1.

Interventions

[14C]-GDC-0810

Participants will receive a single 300-mg dose of GDC-0810 containing approximately 100 microcuries of \[14C\]-labeled GDC-0810 on Day 1.

Intervention Type: DRUG

Other Intervention Names

ARN-810; RO7056118

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

GP29916

Identifier Type: -

Identifier Source: org_study_id