Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 706321 in Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Design Study)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Study Overview
Brief Summary
To investigate the pharmacokinetics of a single oral dose of BI 706321 when given alone or in combination with itraconazole.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (body temperature, 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 GCP and local legislation
Exclusion Criteria
- •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
- •During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection Further exclusion criteria apply.
Arms & Interventions
BI 706321 (Reference (R))/ BI 706321 + Itraconazole (Test (T))
On trial day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 2 milligram (mg) BI 706321 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
In treatment period 2: 200 mg itraconazole was administered as an oral solution formulation (concentration: 20 mL of 10 mg/mL) once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2. On day 1 of period 2 (1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet of 2 mg BI 706321 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
There was a washout interval of at least 14 days between the administrations of BI 706321 in the 2 trial periods.
Intervention: BI 706321 (Drug)
BI 706321 (Reference (R))/ BI 706321 + Itraconazole (Test (T))
On trial day 1 of treatment period 1, a single oral dose of 1 film-coated tablet of 2 milligram (mg) BI 706321 was administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R).
In treatment period 2: 200 mg itraconazole was administered as an oral solution formulation (concentration: 20 mL of 10 mg/mL) once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2. On day 1 of period 2 (1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet of 2 mg BI 706321 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)).
There was a washout interval of at least 14 days between the administrations of BI 706321 in the 2 trial periods.
Intervention: Itraconazole (Drug)
Outcomes
Primary Outcomes
Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time Frame: Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.
Area under the concentration-time curve of BI 706321 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Maximum Measured Concentration of BI 706321 in Plasma (Cmax)
Time Frame: Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.
Maximum measured concentration of BI 706321 in plasma (Cmax).
Secondary Outcomes
- Area Under the Concentration-time Curve of BI 706321 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)(Within 3 hours (h) (1h for period 2) before and at 0.5h to 190h after BI 706321 administration in each period. Further at 214h to 550h after BI 706321 administration in period 2.)