A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet

NCT01287091 | Completed Phase 1

• 1 other identifier: PIM4930g
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (6)

• Maximum plasma concentration

  Up to day 10

• Time to maximum observed plasma concentration

  Up to day 10

• Plasma half-life

  Up to day 10

• Oral clearance

  Up to day 10

• Volume of distribution

  Up to day 10

• Minimum plasma concentration

  Up to day 10

Secondary Outcomes (3)

• Incidence of adverse events

  Up to day 68

• Nature of adverse events

  Up to day 68

• Severity of adverse events

  Up to day 68

Study Arms (4)

Part 1

EXPERIMENTAL

Drug: GDC-0980

Part 2

EXPERIMENTAL

Drug: GDC-0980

Part 3: Group A

EXPERIMENTAL

Drug: GDC-0980; Drug: rabeprazole

Part 3: Group B

EXPERIMENTAL

Drug: GDC-0980; Drug: rabeprazole

Interventions

GDC-0980 DRUG

Oral tablet dose

Part 1

rabeprazole DRUG

Oral repeating dose

Part 3: Group A; Part 3: Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonsmoking with a body mass index of 18 to 32 kg/m2
• Medically healthy as determined by the absence of clinically significant findings in the physical examination, medical history, vital sign measurements, clinical laboratory tests, or 12-lead electrocardiograms (ECGs)
• Nonchildbearing potential, defined as either postmenopausal and without recent history of menorrhea or surgically sterile

You may not qualify if:

• History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, or psychiatric disorders, or cancer
• History of inflammatory arthritis
• History of symptomatic hypotension
• History of severe physical injury, direct impact trauma, or neurological trauma within 6 months prior to study start
• History of seizure disorders
• History of bipolar or major depressive disorder
• History of stomach or intestinal surgery or resection that could potentially alter absorption and/or excretion of orally administered drugs with the exception of appendectomy, hernia repair, and cholecystectomy, which are allowed
• History or presence of an abnormal ECG
• History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
• Abnormality on the chest x-ray at Screening
• History of alcoholism, drug abuse, or drug addiction
• Used any nicotine-containing or nicotine-replacement products within 6 months prior to study start
• Participated in any other investigational drug study in which receipt of an investigational study drug occurred within 1 month or 5 half-lives prior to study start
• Used any prescription medications/products including monoamine oxidase inhibitors, thioridazine, pimozide, or antidepressants within 1 month (2 weeks for antibiotics) prior to study start, with the exception of hormone-replacement therapy or 2 weeks' use of narcotics for pain
• Received any vaccination or immunization within 1 month prior to study start

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

Investigational Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one; Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Scott Holden, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: February 1, 2011
• Study Start: October 14, 2010
• Primary Completion: February 3, 2011
• Study Completion: February 3, 2011
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

US (1)