The main objectives are:
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Drug: BI 706321 Drug: Placebo | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 61 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) |
| Actual Study Start Date : | June 18, 2019 |
| Actual Primary Completion Date : | December 4, 2020 |
| Actual Study Completion Date : | December 4, 2020 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: BI 706321 |
Drug: BI 706321
Capsule or Oral Solution
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| Placebo Comparator: Placebo |
Drug: Placebo
Capsule or Oral solution
|
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Germany | |
| Humanpharmakologisches Zentrum Biberach | |
| Biberach, Germany, 88397 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 31, 2019 | ||||
| First Posted Date ICMJE | June 3, 2019 | ||||
| Last Update Posted Date | December 10, 2020 | ||||
| Actual Study Start Date ICMJE | June 18, 2019 | ||||
| Actual Primary Completion Date | December 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Safety and tolerability of BI 706321 is the percentage of subjects with drug-related adverse events. [ Time Frame: Up to 22 Days ] | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Test How Well Healthy Men Tolerate Different Doses of BI 706321 | ||||
| Official Title ICMJE | Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 706321 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) | ||||
| Brief Summary |
The main objectives are:
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
61 | ||||
| Original Estimated Enrollment ICMJE |
80 | ||||
| Actual Study Completion Date ICMJE | December 4, 2020 | ||||
| Actual Primary Completion Date | December 4, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03971695 | ||||
| Other Study ID Numbers ICMJE | 1425-0001 2019-000888-25 ( EudraCT Number ) |
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| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Boehringer Ingelheim | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Boehringer Ingelheim | ||||
| Verification Date | December 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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