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Sorafenib Drug Drug Interaction Study in Healthy Male Subjects

NCT02332031 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-10-12

No results posted yet for this study

Summary

To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and elimination of sorafenib and safety in healthy male subjects

Conditions

  • Drug Interactions

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Single dose of 400 mg orally on Period 1 Day 1 and Period 2 Day 11

DRUG

Levothyroxine

Single dose of 300 mcq orally from Period 2 Day 1 to Period 2 Day 14

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-06-30
Completion
2015-09-30

Countries

  • Germany

Study Locations

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Entities

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 NCT02332031 on ClinicalTrials.gov