NCT02699710

Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects

A Phase I, Single Center, Randomized, Open-Label, Study Investigating the Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics of GDC-0853 and the Effect of GDC-0853 on the Pharmacokinetics of Methotrexate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase I, single center, randomized (Parts 1 and 2 only), open-label, 3 part study. Parts 1 and 2 are 2-way crossover, with 1-fixed sequence, 3-period designs to investigate the effect of formulation, food and rabeprazole on the PK of GDC-0853 in healthy male and female (of non-childbearing potential) participants. Part 3 is a fixed-sequence study with 3 treatments to characterize the steady-state PK of the GDC-0853 tablet; the effect of simultaneous administration of a single dose of methotrexate on the steady-state kinetics of GDC-0853; and the effect of dosing GDC-0853 to steady-state on the single dose PK of methotrexate in healthy male participants.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Folic Acid	Folic acid will be administered orally as tablet at a single dose of 5 mg.
DRUG	GDC-0853	GDC-0853 will be administered orally as tablet or capsule at a dose of 200 mg.
DRUG	Methotrexate	Methotrexate will be administered orally as tablet at a single dose of 7.5 mg.
DRUG	Rabeprazole	Rabeprazole will be administered orally as tablet at a dose of 20 mg.

Timeline

• Start date: 2015-09-03
• Primary completion: 2016-05-26
• Completion: 2016-05-26
• First posted: 2016-03-04
• Last updated: 2020-03-02

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study