Clinical Trials Logo
  1. Home
  2. Healthy Volunteers
  3. 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 — QCL117578  

Healthy Volunteer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02699710
Study type Interventional
Source Genentech, Inc.
Contact
Status Completed
Phase Phase 1
Start date September 3, 2015
Completion date May 26, 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT06326723 - Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects Phase 1
Recruiting NCT00001367 - Diagnosis and History Study of Patients With Different Neurological Conditions
Completed NCT02231892 - Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study N/A
Not yet recruiting NCT06441916 - Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions Phase 1
Completed NCT03771586 - A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects Phase 1
Not yet recruiting NCT06337422 - Bioequivalence Study of Generic Celecoxib 200 mg Capsules Phase 1
Completed NCT03302182 - Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects Phase 1
Completed NCT05049343 - Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants Phase 1
Recruiting NCT01629108 - Normal Values in Hearing and Balance Testing
Completed NCT02947854 - Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant Phase 1
Completed NCT02534870 - Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects Phase 1
Completed NCT02224053 - Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers Phase 1
Completed NCT01697436 - A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets Phase 1
Completed NCT01676584 - A Study of Single Dose RO6811135 in Healthy Volunteers Phase 1
Completed NCT01684891 - A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers Phase 1
Completed NCT01711762 - A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers Phase 1
Completed NCT01591850 - A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers Phase 1
Completed NCT01414881 - Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects Phase 1
Completed NCT01579149 - A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent Phase 1
Completed NCT02547259 - Influence of Emotion in a Test Run Forgetfulness N/A