A Study in Healthy Men to Test How Different Doses of BI 1595043 Are Tolerated

NCT04439838 | Completed Phase 1 Results

• 2 other identifiers: 1445-00012020-001036-10
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1595043 in healthy male subjects following oral administration of single rising doses.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Drug-related Adverse Events (AEs)

  Percentage of participants with drug-related adverse events (AEs) is reported.

  From drug administration until end of trial, up to 15 days.

Secondary Outcomes (2)

• Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)

  Within 3 hours prior to drug administration and 0.5, 1, 1.5, 2*, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 168 and 192 hours after drug administration. * Only for dose group "12 mg BI 1595043".

• Maximum Measured Concentration of BI 1595043 in Plasma (Cmax)

  Within 3 hours prior to drug administration and 0.5, 1, 1.5, 2*, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 168 and 192 hours after drug administration. * Only for dose group "12 mg BI 1595043".

Study Arms (9)

1 mg BI 1595043

EXPERIMENTAL

1 mg BI 1595043

Drug: BI 1595043

3 mg BI 1595043

EXPERIMENTAL

3 mg BI 1595043

Drug: BI 1595043

6 mg BI 1595043

EXPERIMENTAL

6 mg BI 1595043

Drug: BI 1595043

12 mg BI 1595043

EXPERIMENTAL

12 mg BI 1595043

Drug: BI 1595043

25 mg BI 1595043

EXPERIMENTAL

25 mg BI 1595043

Drug: BI 1595043

50 mg BI 1595043

EXPERIMENTAL

50 mg BI 1595043

Drug: BI 1595043

90 mg BI 1595043

EXPERIMENTAL

90 mg BI 1595043

Drug: BI 1595043

160 mg BI 1595043

EXPERIMENTAL

160 mg BI 1595043

Drug: BI 1595043

Matching Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

BI 1595043 DRUG

BI 1595043

1 mg BI 1595043; 12 mg BI 1595043; 160 mg BI 1595043; 25 mg BI 1595043; 3 mg BI 1595043; 50 mg BI 1595043; 6 mg BI 1595043; 90 mg BI 1595043

Placebo DRUG

Placebo

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the assessment of the investigator, as 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 50 years (inclusive)
• 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
• Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
• Use of adequate contraception, e.g. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea
• Sexually abstinent
• Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (e.g. condom)
• Unprotected sexual intercourse with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: August 13, 2020
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: February 21, 2024
• Results First Posted: February 21, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)