Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin

NCT01770392 | Completed Phase 1 Results

• 2 other identifiers: 1199.1622012-002507-18
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of nintedanib

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)

  AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib

• Maximum Measured Concentration (Cmax)

  Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

  1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib

Secondary Outcomes (1)

• Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)

  1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib

Study Arms (2)

Test

ACTIVE COMPARATOR

multiple doses of Rifampicin + single dose of Nintedanib

Drug: Rifampicin; Drug: Nintedanib

Reference

EXPERIMENTAL

single dose of Nintedanib

Drug: Nintedanib

Interventions

Nintedanib DRUG

single dose administration

Reference

Rifampicin DRUG

single dose once daily for 7 days

Test

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy male subjects

You may not qualify if:

• \. Any relevant deviation from healthy conditions

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1199.162.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Related Publications (1)

• Luedtke D, Marzin K, Jungnik A, von Wangenheim U, Dallinger C. Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2018 Oct;43(5):533-541. doi: 10.1007/s13318-018-0467-9.

  PMID: 29500603 DERIVED

MeSH Terms

Interventions

nintedanib; Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 17, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 27, 2014
• Results First Posted: November 27, 2014

Record last verified: 2014-11

Locations

DE (1)