This Study Tests How Healthy Men Tolerate Different Doses of BI 730357 and How the Metabolism of Midazolam is Affected by BI 730357

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03279978
• Collaborator: (none)
• Enrollment: 83
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief Summary

Phase Ib evaluation of the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) properties of Multiple Rising Dose (MRD) administration of BI 730357 to healthy volunteers for up to 28 days.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Psoriasis	Drug: BI 730357; Drug: Placebo; Drug: Midazolam	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase Ib Evaluation of the Safety and Tolerability and Effect on Midazolam Metabolism of the Administration of Multiple Rising Doses of BI 730357 to Healthy Volunteers
• Actual Study Start Date: Jan 9, 2018
• Actual Primary Completion Date: Aug 24, 2018
• Actual Study Completion Date: Aug 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 730357	Drug: BI 730357; up to 28 days; Drug: Midazolam; Dose groups 4 & 5 only
Placebo Comparator: Placebo	Drug: Placebo; up to 28 days; Drug: Midazolam; Dose groups 4 & 5 only

Outcome Measures

Primary Outcome Measures

1. Number of subjects with drug-related Adverse Events (AEs) [up to 5 weeks]

Secondary Outcome Measures

1. AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose) [Week 4]

2. After the first dose: Cmax (maximum measured concentration of the analyte in plasma) [Week 4]

3. After the last dose: AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) [Week 4]

4. After the last dose:Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau) [Week 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male subjects according to the assessment of the Investigator, based on a complete medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

• Subjects with a partner who is a woman of childbearing potential (WOCBP) must be willing to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication

• Age of 18 to 45 years (incl.) at screening

• Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.) at screening

• Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation

Exclusion criteria

• Any finding in the medical examination (including blood pressure, pulse rate or Electrocardiogram (ECG)) 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 beats per minute (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 (except appendectomy and simple hernia repair) that could interfere with the PK of the trial medication

• Diseases of the Central Nervous System (CNS) (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 acute infections which are of relevance in the opinion of the Investigator

• 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

• Tobacco usage (more than 10 cigarettes or 3 cigars or 3 pipes per day)

• Alcohol abuse (consumption of more than 30 g per day)

• Drug abuse or positive drug screening

• Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial

• Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial

• A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)

• Subject is assessed as unsuitable for inclusion by the Investigator; for instance, is considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study

• Unwillingness to adhere to the rules of UV-light protection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CTC North GmbH & Co. KG, Hamburg	Hamburg		Germany	20251

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03279978
• Other Study ID Numbers: 1407-0002; 2017-001653-14
• First Posted: Sep 12, 2017
• Last Update Posted: Nov 7, 2018
• Last Verified: Nov 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis; Midazolam

Study Results

No Results Posted as of Nov 7, 2018