Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects

NCT03195088 | Terminated Phase 1 Results

• 2 other identifiers: 1400-00012016-003224-24
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of single rising doses of BI 473494 in healthy male subjects. The secondary objective is the exploration of PK including dose proportionality, and PD of BI 473494 after single dosing.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Drug-related Adverse Events (AEs) Analysed as Investigator Defined Drug-related AEs

  Percentage of participants with drug-related adverse events (AEs) analysed as investigator defined drug-related AEs is presented. Medical judgment was used to determine the relationship between the AEs and the study medication, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history.

  From drug administration until End of trial (EOT), up to 40 days.

Secondary Outcomes (2)

• Area Under the Concentration-time Curve of BI 473494 Over the Time Interval From 0 to the Last Quantifiable Time Point (AUC0-tz)

  Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1

• Maximum Measured Concentration of BI 473494 (Cmax)

  Pharmacokinetic samples were taken 1:00 hour:minute (h:m) pre-dose and 3:00, 6:00, 9:00, 12:00, 15:00 , 22:00, 24:00, 28:00, 34:00, 39:00, 48:00, 60:00, 72:00, 96:00, 120:00, 168:00, 240:00, 336:00, 504:00 and 672:00 h:m after drug administration on day 1

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Healthy participants were administered a single dose of placebo matching BI 473494 solution via subcutaneous injection.

Drug: Placebo

BI 473494 35 μg

EXPERIMENTAL

Healthy participants were administered a single dose of 35 micrograms (μg) BI 473494 solution via subcutaneous injection.

Drug: BI 473494

BI 473494 75 μg

EXPERIMENTAL

Healthy participants were administered a single dose of 75 micrograms (μg) BI 473494 solution via subcutaneous injection.

Drug: BI 473494

Interventions

BI 473494 DRUG

Solution for injection

BI 473494 35 μg; BI 473494 75 μg

Placebo DRUG

Solution for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 45 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, based on a complete medical history including a physical examination, vital signs (Blood Pressure \[BP\], Pulse Rate \[PR\]), 12-lead Electrocardiogram \[ECG\], and clinical laboratory tests
• Age of 18 to 45 years (incl.)
• Body Mass Index \[BMI\] of 20.0 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice \[GCP\] and local legislation

You may not qualify if:

• Any finding in the medical examination (including Blood Pressure \[BP\], Pulse Rate \[PR\] or Electrocardiogram \[ECG\]) 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 50 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
• 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)
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, Germany

Location

Limitations and Caveats

The study was terminated due to business reasons after the second of 11 planned dose groups. Therefore, only two dose groups were evaluated.

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: 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 20, 2017
• First Posted: June 22, 2017
• Study Start: July 27, 2017
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: July 14, 2022
• Results First Posted: June 22, 2022

Record last verified: 2022-06

Locations

DE (1)