To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1467335 Following Multiple Dose Administration Over 28 Days

NCT02733627 | Completed Phase 1 Results

• 2 other identifiers: 1386.82015-005049-29
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1467335 in healthy male and female subjects following oral administration of multiple rising doses over 28 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and target engagement biomarkers of BI 1467335 after multiple dosing.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Investigator Defined Drug-related Adverse Events

  Number of subjects with investigator defined drug-related adverse events (AEs) is reported.

  From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.

Secondary Outcomes (4)

• Cmax

  0:00 hour (h) (within 30 minutes prior to dosing) and 0:15 h, 0:30 h, 0:45 h, 1:00 h, 1:30 h, 2:00 h, 3:00 h, 4:00 h, 6:00 h, 8:00 h, 10:00 h, 12:00 h and 24:00 h after drug administration on Day 1.

• AUC0-24

  0:00 hour (h) (within 30 minutes prior to dosing) and 0:15 h, 0:30 h, 0:45 h, 1:00 h, 1:30 h, 2:00 h, 3:00 h, 4:00 h, 6:00 h, 8:00 h, 10:00 h, 12:00 h and 24:00 h after drug administration on Day 1.

• Cmax,28

  648:00 hours (h) (within 30 minutes prior to dosing) and 648:15 h, 648:30 h, 648:45 h, 649:00h, 649:30 h, 650:00 h, 651:00 h, 652:00 h, 654:00 h, 656:00 h, 658:00 h, 660:00 h, 672:00 h after first drug administration on Day 1.

• AUC0-24,28

  648:00 hours (h) (within 30 minutes prior to dosing) and 648:15 h, 648:30 h, 648:45 h, 649:00 h, 649:30 h, 650:00 h, 651:00 h, 652:00 h, 654:00 h, 656:00 h, 658:00 h, 660:00 h and 672:00 h after first drug administration on Day 1.

Study Arms (4)

BI 1467335 10 mg (low dose)

EXPERIMENTAL

Drug: BI 1467335

BI 1467335 15 mg (medium dose)

EXPERIMENTAL

Drug: BI 1467335

BI 1467335 20 mg (high dose)

EXPERIMENTAL

Drug: BI 1467335

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1467335 DRUG

BI 1467335 10 mg (low dose); BI 1467335 15 mg (medium dose); BI 1467335 20 mg (high dose)

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy male or female subjects according to the investigator's assessment, 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
• Age of 18 to 50 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
• 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:
• Surgically sterilised (including hysterectomy)
• Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of Follicle Stimulating Hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

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)
• Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
• Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
• Used nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff) within 6 weeks before screening and unable to abstain from using these products until study completion
• Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

CRS Clinical Research Services Mannheim GmbH

Mannheim, 68167, 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

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 11, 2016
• Study Start: July 7, 2016
• Primary Completion: July 12, 2017
• Study Completion: July 12, 2017
• Last Updated: June 7, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-05

Locations

DE (1)