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A Study to Test How Well Men Tolerate Different Doses of BI 3006337

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05076422
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
12.9
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration of single-rising doses.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 3006337
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 3006337 in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel (Sequential) Group Design)
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
Oct 13, 2022
Anticipated Study Completion Date :
Nov 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BI 3006337 treatment group

BI 3006337

Drug: BI 3006337
BI 3006337
Placebo Comparator: Placebo group

Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Percentage of subjects with drug-related adverse events (AEs) [Up to 40 days]

Secondary Outcome Measures

  1. Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) [Up to 40 days]

  2. Maximum measured concentration of the analyte in serum (Cmax) [Up to 40 days]

  3. Time from dosing to the maximum measured concentration of the analyte in serum (tmax) [Up to 40 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
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 (Temperature, blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests

  • Age of ≥18 to ≤55 years at screening (SCR)

  • BMI of ≥20.0 to <32.0 kg/m2 at SCR

  • A minimum absolute body weight (BW) of 70 kilograms (kg) at SCR

  • Male subjects who meet any of the following criteria from the administration of trial medication until 30 days after administration of trial medication:

  • Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom or sexually abstinence (if lifestyle-related): implants, injectables, vaginal contraceptives, intrauterine device, oral contraception (failure rate <1%). In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

  • Surgically sterilised/vasectomised (including hysterectomy with or without bilateral salpingectomy or bilateral oophorectomy of female partner. In case of salpingectomy or oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment).

  • Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea.

  • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

  • Female gender

  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

  • 3 times repeated measurement of systolic BP outside the range of 90 to 150 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 40 to 100 bpm. In case of documented white coat hypertension the decision for eligibility is left to the investigator.

  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters Alanine Transaminase (ALT) (1.25xupper limit of normal (ULN)), Aspartate Transaminase (AST) (1.25xULN) and Total Bilirubin (T-BIL) (1.5xULN) or renal parameters (creatinine 1.25xULN) exceeding the Upper Limit of Normal (ULN) as specified: after 2 times repeated measurements

  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator

  • Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

  • 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, including positive tests for Hepatitis (Hep) B antigen/ Hep C antibodies, Human immunodeficiency virus (HIV)-1/2 antibodies and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

  • Further exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 SGS Life Science Services - Clinical Research Edegem Belgium 2650

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05076422
Other Study ID Numbers:
  • 1466-0001
  • 2020-002600-38
First Posted:
Oct 13, 2021
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 23, 2022