NCT01679613

Brief Summary

The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 27, 2014

Completed
Last Updated

November 27, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

September 3, 2012

Results QC Date

November 14, 2014

Last Update Submit

November 26, 2014

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 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration

  • 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 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration

Secondary Outcomes (1)

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

    1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration

Study Arms (4)

1 Nintedanib (Reference)

EXPERIMENTAL

single dose, oral with 240 ml water

Drug: Nintedanib

2 Nintedanib + Ketoconazole (Test)

EXPERIMENTAL

Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water

Drug: KetoconazoleDrug: Nintedanib

3 Nintedanib (Reference)

EXPERIMENTAL

single dose, oral with 240 ml water

Drug: Nintedanib

4 Nintedanib + Ketoconazole (Test)

EXPERIMENTAL

Nintedanib single dose, Ketoconazole steady state, oral with 240 ml water

Drug: NintedanibDrug: Ketoconazole

Interventions

NintedanibDRUG

low or medium dose depending on pilot part

3 Nintedanib (Reference)
KetoconazoleDRUG

oral administration

2 Nintedanib + Ketoconazole (Test)

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. healthy male subjects

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1199.161.1 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: 29500603DERIVED

MeSH Terms

Interventions

nintedanibKetoconazole

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic 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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 6, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 27, 2014

Results First Posted

November 27, 2014

Record last verified: 2014-11

Locations

DE(1)