Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers

NCT02248259 | Completed Phase 1 Results

• 1 other identifier: 1289.23
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-infinity of BI 409306 and Its Metabolites

  Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 409306 and its metabolites CD 13896 and CD 14084

  1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration

• Cmax of BI 409306 and Its Metabolites

  Maximum measured concentration of the analyte in plasma (Cmax) of BI 409306 and its metabolites CD 13896 and CD 14084

  1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration

Secondary Outcomes (3)

• AUC0-tz of BI 409306 and Its Metabolites

  1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration

• Tmax of BI 409306 and Its Metabolites

  1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration

• t1/2 of BI 409306 and Its Metabolites

  1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration

Study Arms (4)

Extensive Metabolisers: Ref / Test

EXPERIMENTAL

Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.

Drug: BI 409306; Drug: Itraconazole

Poor Metabolisers: Ref / Test

EXPERIMENTAL

Participants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.

Drug: BI 409306; Drug: Itraconazole

Extensive Metabolisers: Test / Ref

EXPERIMENTAL

Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).

Drug: BI 409306; Drug: Itraconazole

Poor Metabolisers: Test / Ref

EXPERIMENTAL

Participants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).

Drug: BI 409306; Drug: Itraconazole

Interventions

BI 409306 DRUG

Oral single dose of BI 409306

Extensive Metabolisers: Ref / Test; Extensive Metabolisers: Test / Ref; Poor Metabolisers: Ref / Test; Poor Metabolisers: Test / Ref

Itraconazole DRUG

Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole

Extensive Metabolisers: Ref / Test; Extensive Metabolisers: Test / Ref; Poor Metabolisers: Ref / Test; Poor Metabolisers: Test / Ref

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Healthy CYP2C19 genotyped male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR, respiratory rate, body temperature), 12-lead ECG, ophthalmologic exam, clinical laboratory tests
• Korean ethnicity according to the following criteria: be a current Korean passport or national identification card holder, and have parents and grandparents who were all born in Korea
• Age 20 or older than 20 and 45 or younger than 45 years
• BMI (Body Mass Index) 18.5 or more than 18.5 and BMI 25 or less than 25 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

You may not qualify if:

• Any finding of the medical examination (including BP, PR, respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy, hernia surgery)
• Diseases of the central nervous system (including but not limited to any kind of seizures, migraine, stroke or psychiatric disorders) within the past 6 month
• History of relevant orthostatic hypotension, fainting spells or blackouts.
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (longer than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 20 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1289.23.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

MeSH Terms

Interventions

BI 409306; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

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

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: 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: September 22, 2014
• First Posted: September 25, 2014
• Study Start: October 8, 2014
• Primary Completion: January 7, 2015
• Study Completion: January 8, 2015
• Last Updated: April 25, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)