HealthyPhase 1NCT04938453

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

A Phase 1 study testing nintedanib 25 mg and nintedanib 100 mg in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: nintedanib 25 mg and nintedanib 100 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteGermany
Study dates: 14 Jul 2021to 30 Aug 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

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)

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
Being tested: nintedanib 25 mg, nintedanib 100 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

nintedanib 25 mgDrug
soft gelatin capsule
nintedanib 100 mgDrug
Also called Ofev®
soft gelatin capsule

Study groups in NCT04938453
Study group	Role	What they receive
nintedanib 4 X 25 mg (T) then nintedanib 1 X 100 mg (R))	Experimental	first test (T), then reference (R) treatment Receives: 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 Receives: Drug: nintedanib 25 mg; Drug: nintedanib 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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-∞)
Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 202130 Aug 2021

First posted24 Jun 2021
Study start14 Jul 2021
Primary completion30 Aug 2021
Study completion30 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04938453
Sponsor's protocol ID: 1199-0463
Other IDs: 2021-001052-34
Status last verified: Aug 2022
First submitted: 23 Jun 2021
Last updated: 17 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04938453
Acronym / sponsor ID: 1199-0463
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 14 Jul 2021 (actual)
Primary completion: 30 Aug 2021 (actual)
Study completion: 30 Aug 2021 (actual)
First posted: 24 Jun 2021 (actual)
Results: Posted 17 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
nintedanib 4 X 25 mg (T) then nintedanib 1 X 100 mg (R))	Experimental	Drug: nintedanib 25 mg, Drug: nintedanib 100 mgfirst test (T), then reference (R) treatment
nintedanib 1 X 100 mg (R) then nintedanib 4 X 25 mg (T)	Experimental	Drug: nintedanib 25 mg, Drug: nintedanib 100 mgfirst reference (R), then test (T) treatment

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nintedanib 25 mgsoft gelatin capsule	Drug	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 mgAlso: Ofev®soft gelatin capsule	Drug	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))

Primary outcome

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)
Time frame: 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.
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.
Maximum Measured Concentration of Nintedanib in Plasma (Cmax)
Time frame: 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) is reported.

1 secondary outcome

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

Results and safety

Results posted to the registry on 17 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nintedanib 1 X 100 mg (R) / Nintedanib 4 X 25 mg (T)	10	10
Nintedanib 4 X 25 mg (T) / Nintedanib 1 X 100 mg (R)	10	10

Primary outcome: 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)

Time frame: 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.. Geometric least squares mean (Standard Error). Unit: hours (h) *nanogram(ng)/milliliter (mL)

Measure	Nintedanib 1 X 100 mg (R) n = 19	Nintedanib 4 X 25 mg (T) n = 19
Value	150.65 (NA)	148.34 (NA)

Nintedanib 1 X 100 mg (R) vs Nintedanib 4 X 25 mg (T): Ratio of GLSMs (%): 98.47 (90% CI 90.87 to 106.69)

Population analysed: Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least 1 PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment.

Primary outcome: Maximum Measured Concentration of Nintedanib in Plasma (Cmax)

Measure	Nintedanib 1 X 100 mg (R) n = 19	Nintedanib 4 X 25 mg (T) n = 19
Value	15.23 (NA)	15.27 (NA)

Nintedanib 1 X 100 mg (R) vs Nintedanib 4 X 25 mg (T): Ratio of GLSMs (%): 100.29 (90% CI 85.05 to 118.24)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For both arms: From drug administration until 14 days thereafter.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nintedanib 1 X 100 mg (R)	0 of 19 (0%)	10 of 19 (52.6%)	0 of 19
Nintedanib 4 X 25 mg (T)	0 of 19 (0%)	5 of 19 (26.3%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing nintedanib 25 mg and nintedanib 100 mg in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04938453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.