A Study in Healthy Men to Test Whether Four Capsules of 25 mg Nintedanib Are Taken up in the Body in the Same Way as One 100 mg Capsule

NCT04938453 | Completed Phase 1 Results

• 2 other identifiers: 1199-04632021-001052-34
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of 100 mg nintedanib given as four capsules of 25 mg nintedanib compared with one capsule of 100 mg nintedanib.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of the Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of the nintedanib in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.

  For both arms: Within 3 hours (h) before and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h, 34 h, 48 h and 72h after nintedanib administration.

• Maximum Measured Concentration of Nintedanib in Plasma (Cmax)

  Maximum measured concentration of nintedanib in plasma (Cmax) is reported.

  For both arms: Within 3 hours (h) before and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h, 34 h, 48 h and 72h after nintedanib administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  For both arms: Within 3 hours (h) before and 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 24 h, 34 h, 48 h and 72h after nintedanib administration.

Study Arms (2)

nintedanib 4 X 25 mg (T) then nintedanib 1 X 100 mg (R))

EXPERIMENTAL

first test (T), then reference (R) treatment

Drug: nintedanib 25 mg; Drug: nintedanib 100 mg

nintedanib 1 X 100 mg (R) then nintedanib 4 X 25 mg (T)

EXPERIMENTAL

first reference (R), then test (T) treatment

Drug: nintedanib 25 mg; Drug: nintedanib 100 mg

Interventions

nintedanib 25 mg DRUG

soft gelatin capsule

nintedanib 1 X 100 mg (R) then nintedanib 4 X 25 mg (T); nintedanib 4 X 25 mg (T) then nintedanib 1 X 100 mg (R))

nintedanib 100 mg DRUG

soft gelatin capsule

Also known as: Ofev®

nintedanib 1 X 100 mg (R) then nintedanib 4 X 25 mg (T); nintedanib 4 X 25 mg (T) then nintedanib 1 X 100 mg (R))

Eligibility Criteria

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

You may qualify if:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

nintedanib

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: 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: June 23, 2021
• First Posted: June 24, 2021
• Study Start: July 14, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)