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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01136174
• Date of registration: 31/05/2010
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: Safety and PK Study of BIBF 1120 in Japanese Patients With IPF
• Scientific title: A Double-blind, Randomised, Placebo-controlled (Within a Dose Group) Study to Evaluate Safety and Pharmacokinetics of Multiple Rising Doses of BIBF 1120 at 50 mg Bid (14 Days), 100 mg Bid (14 Days), and 150 mg Bid (28 Days) p.o., on Top of Standard Medical Care With Stratification According to Pirfenidone Use, in Japanese Patients With Idiopathic Pulmonary Fibrosis.
• Date of first enrolment: May 2010
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01136174
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

1. Diagnosis of idiopathic pulmonary fibrosis (IPF) according to American Thoracic
Society (ATS) /European Respiratory Society (ERS) guideline

2. Forced vital capacity (FVC) 50-90%

3. Diffusing capacity for carbon monoxide (DLCO) 30-79%

4. For patients on pirfenidone, have been on a steady dose for at least 3 months

Exclusion criteria:

1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 x upper limit
of normal range (ULN) at screening.

2. Bilirubin > 1.5 x ULN at screening.

3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC <0.7) at screening.

4. Continuous oxygen supplementation.

5. Active infection at screening or randomisation.

6. Being treated with any of the following concomitant medications.

- Oral corticosteroid medication at unstable dose

- ketoconazole or atazanavir

7. Patients who are expected to go on to lung transplantation, have rapidly deteriorating
disease, or have a life expectancy less than 3 months from screening



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: BIBF 1120

Drug: Placebo

Primary Outcome(s)

Drug-related Adverse Events [Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days]

Secondary Outcome(s)

AUCt,ss After Multiple Doses of BIBF 1120 With Pirfenidone [Time Frame: pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)]

Cmax,ss After Multiple Doses of BIBF 1120 Without Pirfenidone [Time Frame: pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)]

Cmax,ss After Multiple Doses of BIBF 1120 With Pirfenidone [Time Frame: pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)]

AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch) [Time Frame: Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose]

Lung Function Measurement: Diffusing Capacity for Carbon Monoxide Percent of Predicted (%DLco) [Time Frame: baseline and day 35]

Change From Baseline in Pulse Rate [Time Frame: baseline and day 35]

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [Time Frame: baseline and day 35]

Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Lunch) [Time Frame: Day -1 at Visit 1: at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose]

Lung Function Measurement: Forced Vital Capacity (FVC) [Time Frame: baseline and day 35]

Withdrawal Due to Adverse Event [Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days]

AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast) [Time Frame: Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose]

AUCt,ss After Multiple Doses of BIBF 1120 Without Pirfenidone [Time Frame: pre-dose, then 0.5 h, 1 h, 2 h, 3 h, 3.92 h, 6 h, 8 h, 12 h, 24 h, 48 h, 72 h after morning dose on days 14 to 17 (BIBF 1120 50 mg and 100 mg) or on days 28 to 31 (BIBF 1120 150 mg)]

Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch) [Time Frame: Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose]

Clinical Relevant Abnormalities in Laboratory Parameters- With Pirfenidone Background [Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days]

Lung Function Measurement: Diffusing Capacity for Carbon Monoxide (DLco) [Time Frame: baseline and day 35]

AUC0-8,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Lunch) [Time Frame: Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): at pre-dose and 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h after lunch dose]

Clinical Relevant Abnormalities in Laboratory Parameters- No Pirfenidone Background [Time Frame: after the first drug intake until 28 days from the last treatment administration, up to 60 days]

Cmax,ss After Multiple Doses of Pirfenidone 600 mg With BIBF 1120 (After Breakfast) [Time Frame: Day 14 at Visit 5 (BIBF 1120 50mg and 100mg) and day 28 (visit 7) (BIBF 1120 150mg): At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose]

Cmax,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast) [Time Frame: Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose]

AUC0-4,ss After Multiple Doses of Pirfenidone 600 mg Without BIBF 1120 (After Breakfast) [Time Frame: Day -1 at Visit 1: At pre-dose and 0.5 h, 1 h, 2 h, 3 h after morning dose and pre-dose after lunch dose]

Lung Function Measurement: Forced Vital Capacity Percent of Predicted (%FVC) [Time Frame: baseline and day 35]

Lung Function Measurement: Forced Expiratory Volume in 1 Second (FEV1) [Time Frame: baseline and day 35]

Secondary ID(s)

1199.31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/01/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01136174