Drug-drug Interaction Trial Between Rifampicin and BI 409306 in Healthy Volunteers

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03151499
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.4
• Patients Per Site Per Month: 10.9

Study Details

Study Description

Brief Summary

The primary objective of this trial is to investigate the relative bioavailability of BI 409306 tablets with prior 7-day intake of rifampicin tablets (Test, T) compared to BI 409306 tablets without prior administration of rifampicin (Reference, R) following oral administration in healthy male subjects.

The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments. The secondary objectives will be assessed by descriptive statistics.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 409306; Drug: Rifampicin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Rifampicin on the Pharmacokinetics of BI 409306 Following Oral Administration in Healthy Male Subjects (an Open-label, Two-period, Fixed Sequence Trial)
• Actual Study Start Date: May 30, 2017
• Actual Primary Completion Date: Jul 11, 2017
• Actual Study Completion Date: Jul 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Subjects Reference Treatment (BI 409306) given alone followed by Test Treatment (BI 409306 + Rifampicin)	Drug: BI 409306; Reference and Test Treatment; Drug: Rifampicin; Test Treatment

Outcome Measures

Primary Outcome Measures

1. AUC0-tz (area under the concentration-time curve of the analyte (BI 409306) in plasma over the time interval from 0 to the last quantifiable data point) [up to 24 hours]

2. Cmax (maximum measured concentration of the analyte (BI 409306) in plasma) [up to 24 hours]

Secondary Outcome Measures

1. AUC0-∞ (area under the concentration-time curve of the analyte (BI 409306) in plasma over the time interval from 0 extrapolated to infinity) [up to 24 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, 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 (incl.)

• Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)

• 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 (Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged 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 beats per minute (bpm)

• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

• Any evidence of a concomitant disease judged as clinically relevant by the investigator

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and 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 prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)

• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug

• Current smoker or ex-smoker who quit smoking less than 30 days prior to screening.

• Inability to refrain from smoking on specified trial days

• Alcohol abuse (consumption of more than 30 g per day)

• Drug abuse or positive drug screening

• Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial

• Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial

• Inability to comply with dietary regimen of trial site

• Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study

In addition, the following trial-specific exclusion criteria apply:

• History of relevant liver diseases such as disturbance of liver function, jaundice, drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver tumours

• Thrombocytes below lower limit of normal or liver enzymes (ALT, AST, GGT, AP) above upper limit of normal at the screening examination

• Subjects with CYP 2C19 PM status

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

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03151499
• Other Study ID Numbers: 1289-0044; 2016-004828-37
• First Posted: May 12, 2017
• Last Update Posted: Jul 21, 2017
• Last Verified: Jul 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rifampin; BI 409306

Study Results

No Results Posted as of Jul 21, 2017