This Study in Healthy Men Tests How Different Doses of BI 1323495 Are Taken up in the Body and How Well They Are Tolerated.

NCT03588390 | Completed Phase 1 Results

• 2 other identifiers: 1405-00012017-004899-62
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1323495 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality and pharmacodynamics (PD) of BI 1323495 after single dosing and the assessment of the PK/PD relationship.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Drug-related Adverse Events

  Percentage of participants with drug-related adverse events.

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

Secondary Outcomes (2)

• Area Under the Concentration-time Curve of BI 1323495 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration.

• Maximum Measured Concentration of BI 1323495 in Plasma (Cmax)

  1 hour (h) before drug administration and 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 24, 34, 48, 72 and 96 h and additionally 4.75, 5.5, 6.5, 7.5 h for dose group 1/2/3 and 0.333, 0.667, 1.5, 5 h for dose group 4/5/6/7/8 after drug administration.

Study Arms (8)

Dose Group 1

EXPERIMENTAL

Participants were orally administered single dose of BI 1323495 dose group 1 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.

Drug: BI 1323495; Drug: Placebo

Dose Group 2

EXPERIMENTAL

Participants were orally administered single dose of BI 1323495 dose group 2 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.

Drug: BI 1323495; Drug: Placebo

Dose Group 3

EXPERIMENTAL

Participants were orally administered single dose of BI 1323495 dose group 3 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.

Drug: BI 1323495; Drug: Placebo

Dose Group 4

EXPERIMENTAL

Participants were orally administered single dose of BI 1323495 dose group 4 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.

Drug: BI 1323495; Drug: Placebo

Dose Group 5

EXPERIMENTAL

Participants were orally administered single dose of BI 1323495 dose group 5 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.

Drug: BI 1323495; Drug: Placebo

Dose Group 6

EXPERIMENTAL

Participants were orally administered single dose of BI 1323495 dose group 6 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.

Drug: BI 1323495; Drug: Placebo

Dose Group 7

EXPERIMENTAL

Participants were orally administered single dose of BI 1323495 dose group 7 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.

Drug: BI 1323495; Drug: Placebo

Dose Group 8

EXPERIMENTAL

Participants were orally administered single dose of BI 1323495 dose group 8 or matching placebo film-coated tablet with 240 mL of water after an overnight fast of at least 10 h.

Drug: BI 1323495; Drug: Placebo

Interventions

BI 1323495 DRUG

Low strength tablet

Dose Group 1; Dose Group 2; Dose Group 3

Placebo DRUG

Placebo to low strength tablet

Dose Group 1; Dose Group 2; Dose Group 3

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 18.5 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
• 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
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
• Inability to refrain from smoking on specified trial days
• Alcohol abuse (consumption of more than 30 g per day)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 17, 2018
• Study Start: July 31, 2018
• Primary Completion: November 14, 2018
• Study Completion: November 14, 2018
• Last Updated: February 22, 2024
• Results First Posted: February 22, 2024

Record last verified: 2023-07

Locations

DE (1)