MedTrace Logo

Safety and PK Study of BIBF 1120 in Japanese Patients With IPF

NCT01136174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-01-06

Study results available
· View outcomes & findings →

Summary

To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis (IPF), with and without pirfenidone background treatment.

To assess pharmacokinetics of BIBF 1120 in Japanese patients, with and without pirfenidone background treatment.

To assess pharmacokinetics of pirfenidone in Japanese patients, alone and in combination with BIBF 1120 treatment.

Conditions

Interventions

DRUG

Placebo

Placebo BID for cohort 1,2,3

DRUG

BIBF 1120

50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

DRUG

BIBF 1120

50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

DRUG

BIBF 1120

50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-03-31

Countries

  • Japan

More Related Trials

Entities

Drugs
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 NCT01136174 on ClinicalTrials.gov