A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT04537897

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objectives of this trial are to investigate safety and tolerability of BI 474121 in healthy male and female young and elderly subjects following oral administration of multiple rising doses per day over 14 days.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 474121 Drug: Midazolam Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 474121 in Young and Elderly Healthy Male and Female Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design) and Evaluation of Midazolam Interaction in Young Healthy Male and Female Subjects (Nested, Open, Fixed-sequence, Intra-individual Comparison)

Actual Study Start Date :

Oct 6, 2020

Actual Primary Completion Date :

Oct 7, 2021

Actual Study Completion Date :

Oct 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 474121	Drug: BI 474121 BI474121
Experimental: BI 474121 + Midazolam	Drug: BI 474121 BI474121 Drug: Midazolam Midazolam
Placebo Comparator: Placebo group	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: BI 474121

Drug: BI 474121

BI474121

Experimental: BI 474121 + Midazolam

Drug: BI 474121

BI474121

Drug: Midazolam

Midazolam

Placebo Comparator: Placebo group

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Percentage of subjects with drug-related adverse events [Up to 23 days]

Secondary Outcome Measures

Area under the concentration-time curve of the analyte in plasma from 0 to 24h (AUC0-24) [Up to Day 1]
After the first dose of BI 474121
Maximum measured concentration of the analyte in plasma (Cmax) [Up to Day 1]
After the first dose of BI 474121
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) [Up to Day 14]
After the last dose of BI 474121
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) [Up to Day 14]
After the last dose of BI 474121
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [Up to Day 14]
After each of three doses Midazolam
Maximum measured concentration of the analyte in plasma (Cmax) [Up to Day 14]
After each of three doses Midazolam

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male or female 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 45 years (inclusive) for young or 65 to 80 years (inclusive) for elderly healthy volunteers
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

Exclusion Criteria:

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 100 to 140 mm Hg, 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 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
A positive Poly-chain reaction (PCR) test for SARS-CoV-2 and clinical symptoms suggestive for this disease at screening or on Day -3
Further exclusion criteria apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRS Clinical Research Services Mannheim GmbH	Mannheim		Germany	68167

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT04537897

Other Study ID Numbers:

1411-0002
2020-001003-17

First Posted:

Sep 3, 2020

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Midazolam

Study Results

No Results Posted as of Oct 20, 2021