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Drug-drug Interaction (DDI) With a P-gp Inhibitor, Organic Anion Transporting Polypeptide OATP-inhibitor, Food Effect

NCT03116893 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-06-07

No results posted yet for this study

Summary

The primary objective of this trial is to investigate the relative bioavailability of BI 685509 given alone under fasted conditions (Reference, R) compared to the intake after a high fat, high caloric breakfast (Test 1, T1), to combined administration with itraconazole under fasted conditions (Test 2, T2) and to combined administration with rifampin under fasted conditions (Test 3, T3).

The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.

Conditions

  • Healthy

Interventions

DRUG

BI 685509 After Standardised Breakfast

High-fat high calorie breakfast

DRUG

Itraconazole

Administration of itraconazole together with BI 685509

DRUG

Rifampin

Administration of rifampicin together with BI 685509

DRUG

BI 685509 Fasted Conditions

BI 685509, given alone

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-19
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03116893 on ClinicalTrials.gov