This Study in Healthy Men and Women Tests How the Body Takes up BI 409306

NCT03505151 | Completed Phase 1 Results

• 2 other identifiers: 1289-00252017-004798-14
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the absolute bioavailability of BI 409306. The secondary objective is the evaluation and comparison of several pharmacokinetic parameters for the different treatments.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 409306 and Stable Labelled Isotope BI 409306 (C-13/N-15) Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of BI 409306 and stable labelled isotope BI 409306 (C-13/N-15) over the time interval from 0 extrapolated to infinity (AUC0-∞). The dose-normalized values for AUC0-∞ are reported.

  T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

• Maximum Measured Concentration of BI 409306 and Stable Labelled Isotope BI 409306 (C-13/N-15), (Cmax)

  Maximum measured concentration of the analyte BI 409306 and stable labelled isotope BI 409306 (C-13/N-15), (Cmax). The dose-normalized values for Cmax are reported.

  T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

Secondary Outcomes (5)

• Terminal Half-life of BI 409306 and Stable Labelled Isotope BI 409306 (C-13/N-15) in Plasma (t1/2)

  T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

• Time From Dosing to Maximum Measured Concentration of BI 409306 and Stable Labelled Isotope BI 409306 (C-13/N-15) in Plasma (Tmax)

  T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

• For: BI 409306 (C-13/N-15): Total Clearance (CL) of BI 409306 (C-13/N-15)

  Within 3 hours (h) before drug administration, 0.58h, 0.75h, 0.83h, 0.97h, 1.17h, 1.333h, 1.5h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing.

• For BI 409306 (C-13/N-15): Apparent Volume of Distribution During the Terminal Phase After Intravascular Administration (Vz) of BI 409306 (C-13/N-15)

  Within 3 hours (h) before drug administration, 0.58h, 0.75h, 0.83h, 0.97h, 1.17h, 1.333h, 1.5h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing.

• Absolute Bioavailability of BI 409306 (Fabs)

  T and R:Within 3 hours (h) before dosing, 0.75h, 0.97h, 1.333h, 1.75h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h and 24h after dosing. Only T: 0.17h, 0.333h, 0.47h. Only R:0.58h, 0.83h, 1.17h, 1.5h.

Study Arms (1)

BI 409306 tablet + intravenous isotope BI 409306 (C-13/N-15)

EXPERIMENTAL

On day 1, subjects were administered the Test treatment (T): a single dose of 50 milligram (mg) of BI 409306 film-coated tablet orally with 240 milliliter (mL) of water, followed 30 minutes (min) later by the Reference treatment (R): 0.1 mg isotope BI 409306 (C-13/N-15) as intravenous (i.v.) infusion over 30 minutes. Both treatments were given in fasted state.

Drug: BI 409306 (C-13/N-15); Drug: BI 409306

Interventions

BI 409306 (C-13/N-15) DRUG

i.v solution

BI 409306 tablet + intravenous isotope BI 409306 (C-13/N-15)

BI 409306 DRUG

Film-coated tablet

BI 409306 tablet + intravenous isotope BI 409306 (C-13/N-15)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age of 18 to 55 years (incl.)
• 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 GCP and local legislation
• Known CYP 2C19 metabolizer status
• Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
• Use of adequate contraception, e.g. non-hormonal intrauterine device plus condom.
• Sexually abstinent
• A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
• Surgically sterilised (including hysterectomy)
• Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH (follicle stimulating hormone) above 40 U/L and estradiol below 30 ng/L is confirmatory)

You may not qualify if:

• Any finding in the medical examination (including BP, PR or 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 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
• Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)
• Drug abuse or positive drug screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

BI 409306

Limitations and Caveats

Since no balancing of gender was needed according to the Clinical trial protocol, the use of the volunteers' pool of the trial site, in which male subjects are predominant, resulted in only male subjects being included in this trial.

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: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 23, 2018
• Study Start: April 27, 2018
• Primary Completion: May 19, 2018
• Study Completion: May 19, 2018
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)