MedTrace Logo

A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin

NCT03174041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2019-09-24

No results posted yet for this study

Summary

The purpose of this study is to assess the potential for a drug interaction between GDC-0853 and midazolam, itraconazole, rosuvastatin, and simvastatin.

Conditions

  • Healthy Participants

Interventions

DRUG

Midazolam

Single dose midazolam

DRUG

GDC-0853

Multiple doses GDC-0853 for 6 days

DRUG

Midazolam and GDC-0853

Multiple doses GDC-0853 and single dose midazolam

DRUG

Rosuvastatin

Single dose rosuvastatin

DRUG

Rosuvastatin and GDC-0853

Multiple doses GDC-0853 and single dose rosuvastatin

DRUG

Simvastatin

Single dose simvastatin

DRUG

Simvastatin and GDC-0853

Multiple doses GDC-0853 and single dose simvastatin

DRUG

GDC-0853

Single dose GDC-0853

DRUG

Itraconazole

Multiple doses itraconazole for 6 days

DRUG

GDC-0853 and itraconazole

Multiple doses itraconazole and single dose GDC-0853

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2017-06-23
Completion
2017-06-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03174041 on ClinicalTrials.gov