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A Study in Healthy Men to Find the Best Formulation of BI 685509 and to Test How it is Taken up in the Body

NCT ID: NCT04926246

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-02-07

Brief Summary

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The main objective of this trial is to select a formulation and to optimize the identified formulation of BI 685509, if needed.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Study in up to three parts:

Trial part 1: five-period crossover Optional trial part 2: four-period crossover Optional trial part 3: four-period crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: R1-T2-T4-T1-T3

Group Type EXPERIMENTAL

R1: Reference Product X

Intervention Type DRUG

under fasted conditions

T1: Test Product M

Intervention Type DRUG

under fasted conditions

T2: Test Product N

Intervention Type DRUG

under fasted conditions

T3: Test Product O

Intervention Type DRUG

under fasted conditions

T4: Test Product O

Intervention Type DRUG

under fed conditions

Part 1: T1-T4-T2-T3-R1

Group Type EXPERIMENTAL

R1: Reference Product X

Intervention Type DRUG

under fasted conditions

T1: Test Product M

Intervention Type DRUG

under fasted conditions

T2: Test Product N

Intervention Type DRUG

under fasted conditions

T3: Test Product O

Intervention Type DRUG

under fasted conditions

T4: Test Product O

Intervention Type DRUG

under fed conditions

Part 1: T2-T1-T3-R1-T4

Group Type EXPERIMENTAL

R1: Reference Product X

Intervention Type DRUG

under fasted conditions

T1: Test Product M

Intervention Type DRUG

under fasted conditions

T2: Test Product N

Intervention Type DRUG

under fasted conditions

T3: Test Product O

Intervention Type DRUG

under fasted conditions

T4: Test Product O

Intervention Type DRUG

under fed conditions

Part 1: T3-R1-T1-T4-T2

Group Type EXPERIMENTAL

R1: Reference Product X

Intervention Type DRUG

under fasted conditions

T1: Test Product M

Intervention Type DRUG

under fasted conditions

T2: Test Product N

Intervention Type DRUG

under fasted conditions

T3: Test Product O

Intervention Type DRUG

under fasted conditions

T4: Test Product O

Intervention Type DRUG

under fed conditions

Part 1: T4-T3-R1-T2-T1

Group Type EXPERIMENTAL

R1: Reference Product X

Intervention Type DRUG

under fasted conditions

T1: Test Product M

Intervention Type DRUG

under fasted conditions

T2: Test Product N

Intervention Type DRUG

under fasted conditions

T3: Test Product O

Intervention Type DRUG

under fasted conditions

T4: Test Product O

Intervention Type DRUG

under fed conditions

Part 2: R2-T7-T6-T5

Group Type EXPERIMENTAL

R2: Reference Product Y

Intervention Type DRUG

under fasted conditions

T5: Test Product P

Intervention Type DRUG

under fasted conditions

T6: Test Product P

Intervention Type DRUG

under fed conditions

T7: Test Product Q

Intervention Type DRUG

under fasted conditions

Part 2: T5-T6-T7-R2

Group Type EXPERIMENTAL

R2: Reference Product Y

Intervention Type DRUG

under fasted conditions

T5: Test Product P

Intervention Type DRUG

under fasted conditions

T6: Test Product P

Intervention Type DRUG

under fed conditions

T7: Test Product Q

Intervention Type DRUG

under fasted conditions

Part 2: T6-T5-R2-T7

Group Type EXPERIMENTAL

R2: Reference Product Y

Intervention Type DRUG

under fasted conditions

T5: Test Product P

Intervention Type DRUG

under fasted conditions

T6: Test Product P

Intervention Type DRUG

under fed conditions

T7: Test Product Q

Intervention Type DRUG

under fasted conditions

Part 2: T7-R2-T5-T6

Group Type EXPERIMENTAL

R2: Reference Product Y

Intervention Type DRUG

under fasted conditions

T5: Test Product P

Intervention Type DRUG

under fasted conditions

T6: Test Product P

Intervention Type DRUG

under fed conditions

T7: Test Product Q

Intervention Type DRUG

under fasted conditions

Part 3: R3-T10-T9-T8

Group Type EXPERIMENTAL

R3: Reference Product Z

Intervention Type DRUG

under fasted conditions

T8: Test Product S

Intervention Type DRUG

under fasted conditions

T9: Test Product S

Intervention Type DRUG

under fed conditions

T10: Test Product U

Intervention Type DRUG

under fasted conditions

Part 3: T8-T9-T10-R3

Group Type EXPERIMENTAL

R3: Reference Product Z

Intervention Type DRUG

under fasted conditions

T8: Test Product S

Intervention Type DRUG

under fasted conditions

T9: Test Product S

Intervention Type DRUG

under fed conditions

T10: Test Product U

Intervention Type DRUG

under fasted conditions

Part 3: T9-T8-R3-T10

Group Type EXPERIMENTAL

R3: Reference Product Z

Intervention Type DRUG

under fasted conditions

T8: Test Product S

Intervention Type DRUG

under fasted conditions

T9: Test Product S

Intervention Type DRUG

under fed conditions

T10: Test Product U

Intervention Type DRUG

under fasted conditions

Part 3: T10-R3-T8-T9

Group Type EXPERIMENTAL

R3: Reference Product Z

Intervention Type DRUG

under fasted conditions

T8: Test Product S

Intervention Type DRUG

under fasted conditions

T9: Test Product S

Intervention Type DRUG

under fed conditions

T10: Test Product U

Intervention Type DRUG

under fasted conditions

Interventions

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R1: Reference Product X

under fasted conditions

Intervention Type DRUG

T1: Test Product M

under fasted conditions

Intervention Type DRUG

T2: Test Product N

under fasted conditions

Intervention Type DRUG

T3: Test Product O

under fasted conditions

Intervention Type DRUG

T4: Test Product O

under fed conditions

Intervention Type DRUG

R2: Reference Product Y

under fasted conditions

Intervention Type DRUG

T5: Test Product P

under fasted conditions

Intervention Type DRUG

T6: Test Product P

under fed conditions

Intervention Type DRUG

T7: Test Product Q

under fasted conditions

Intervention Type DRUG

R3: Reference Product Z

under fasted conditions

Intervention Type DRUG

T8: Test Product S

under fasted conditions

Intervention Type DRUG

T9: Test Product S

under fed conditions

Intervention Type DRUG

T10: Test Product U

under fasted conditions

Intervention Type DRUG

Eligibility Criteria

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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 (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive) at the time of signing informed consent
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) at the time of signing informed consent
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
* Subjects who are sexually active must use with their partner, highly effective contraception from the time of administration of trial medication until 30 days after administration of trial medication. Adequate methods are:

* Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g., implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or
* Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or
* Condoms plus surgically sterilised partner (including hysterectomy) or
* Condoms plus intrauterine device or
* Condoms plus partner of non-childbearing potential (including homosexual men) Subjects are required to use condoms to prevent unintended exposure of the partner (both, male and female) to the study drug via seminal fluid. Male subjects should use a condom throughout the study and for 30 days after last Investigational Medicinal Product (IMP) administration. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active with their partner, they must comply with the contraceptive requirements detailed above.

Male subjects should not donate sperm for the duration of the study and for at least 30 days after last IMP administration.

Exclusion Criteria

* Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (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 mmHg, diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm at screening and pre-dose of first period
* 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, including not resolved post-vaccination reactions
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological 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, unless within the last 12 months)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Quotient Sciences

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.mystudywindow.com

Related Info

Other Identifiers

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1366-0024

Identifier Type: -

Identifier Source: org_study_id