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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT04938453

Collaborator

(none)

Enrollment

Location

Arms

1.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: nintedanib (formulation A, test treatment) Drug: nintedanib (formulation B, reference treatment)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Relative Bioavailability of 100 mg Nintedanib (Ofev®) Given as Four Capsules of 25 mg Compared to One Capsule of 100 mg Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

Actual Study Start Date :

Jul 14, 2021

Actual Primary Completion Date :

Aug 30, 2021

Actual Study Completion Date :

Aug 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment sequence 1 (T-R) first test (T), then reference (R) treatment	Drug: nintedanib (formulation A, test treatment) nintedanib (formulation A, test treatment) Drug: nintedanib (formulation B, reference treatment) nintedanib (formulation B, reference treatment)
Experimental: Treatment sequence 2 (R-T) first reference (R), then test (T) treatment	Drug: nintedanib (formulation A, test treatment) nintedanib (formulation A, test treatment) Drug: nintedanib (formulation B, reference treatment) nintedanib (formulation B, reference treatment)

Arm

Intervention/Treatment

Experimental: Treatment sequence 1 (T-R)

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

Drug: nintedanib (formulation A, test treatment)

nintedanib (formulation A, test treatment)

Drug: nintedanib (formulation B, reference treatment)

nintedanib (formulation B, reference treatment)

Experimental: Treatment sequence 2 (R-T)

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

Drug: nintedanib (formulation A, test treatment)

nintedanib (formulation A, test treatment)

Drug: nintedanib (formulation B, reference treatment)

nintedanib (formulation B, reference treatment)

Outcome Measures

Primary Outcome Measures

AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) [up to 72 hours]
Cmax (maximum measured concentration of the analyte in plasma) [up to 72 hours]

Secondary Outcome Measures

AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [up to 72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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
History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Humanpharmakologisches Zentrum Biberach	Biberach		Germany	88397

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT04938453

Other Study ID Numbers:

1199-0463
2021-001052-34

First Posted:

Jun 24, 2021

Last Update Posted:

Sep 13, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nintedanib

Study Results

No Results Posted as of Sep 13, 2021