A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 894416 in the Blood

NCT04060719 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 1371-00052019-000507-33
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this trial is to investigate the effect of rifampicin on the pharmacokinetics of BI 894416.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

  Within 3 hours before administration of BI 894416 and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34 and 48 hours after administration of BI 894416.

• Maximum Measured Concentration of BI 894416 in Plasma (Cmax)

  Maximum measured concentration of BI 894416 in plasma (Cmax).

  Within 3 hours before administration of BI 894416 and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34 and 48 hours after administration of BI 894416.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  Within 3 hours before administration of BI 894416 and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34 and 48 hours after administration of BI 894416.

Study Arms (2)

Reference (Period 1) - BI 894416 alone

EXPERIMENTAL

Reference (Period 1) followed by Test (Period 2)

Drug: BI 894416

Test (Period 2) - BI 894416 + Rifampicin

EXPERIMENTAL

Drug: BI 894416; Drug: Rifampicin

Interventions

BI 894416 DRUG

tablet

Reference (Period 1) - BI 894416 alone; Test (Period 2) - BI 894416 + Rifampicin

Rifampicin DRUG

tablet

Test (Period 2) - BI 894416 + Rifampicin

Eligibility Criteria

• Age: 18 Years - 50 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 50 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 Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG) and including the neurological examination) 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
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
• Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
• Smoker (unless the subject quit smoking for at least 3 months prior to first planned administration of trial medication)
• Alcohol abuse (consumption of more than 24 g per day)
• Drug abuse or positive drug screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

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: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 19, 2019
• Study Start: September 4, 2019
• Primary Completion: October 17, 2019
• Study Completion: October 17, 2019
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)