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Drug Interaction Study of SAR302503 in Patients With Solid Tumor

NCT01585623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-03-05

No results posted yet for this study

Summary

Primary Objective:

* To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4).
* To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses.

Secondary Objectives:

* To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1
* To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2
* To determine antitumor activity in Segment 2

Conditions

Interventions

DRUG

SAR302503

Pharmaceutical form:capsule Route of administration: oral

DRUG

omeprazol

Pharmaceutical form:capsule Route of administration: oral

DRUG

metoprolol

Pharmaceutical form:tablet Route of administration: oral

DRUG

midazolam

Pharmaceutical form:solution Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01585623 on ClinicalTrials.gov