I have just noticed another study come online with a different objective. One site in Japan is currently recruiting with an estimated enrollment target of 48 patients (completion Dec 17).
Link:
https://clinicaltrials.gov/ct2/show/NCT03159455?term=BI1467335&recrs=a&rank=1
This Study Tests BI 1467335 in Healthy Japanese and Caucasian Men. The Study Tests How Different Doses of BI 1467335 Are Taken up in the Body and How Well They Are Tolerated
This study is currently recruiting participants.
See 
Contacts and Locations
Verified July 2017 by Boehringer Ingelheim
Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03159455
First received: May 17, 2017
Last updated: July 25, 2017
Last verified: July 2017
History of Changes
Purpose
The primary objective of the current study is to investigate the safety and tolerability of BI 1467335 in healthy Japanese male subjects following oral administration of multiple rising doses The Caucasian group will receive higher dose only.
A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 1467335 in healthy Japanese and Caucasian male subjects.
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Study Type: |
Interventional |
| 1 |
Study Design: |
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Participant, InvestigatorPrimary Purpose: Treatment |
| 2 |
Official Title: |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1467335 in Healthy Japanese Male Volunteers With Multiple Oral Doses at the Highest Dose in Caucasian for Comparison (Randomised, Double-blind, Placebo-controlled Trial) |
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- [N (%)] of subjects with drug-related Adverse Events. [ Time Frame: up to 48 days ]
Secondary Outcome Measures:
- AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours after administration of the first dose) [ Time Frame: up to 24 hours ]
- Cmax (maximum measured concentration of the analyte in plasma after administration of the first dose) [ Time Frame: up to 24 hours ]
- AUC0-24,28 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours after administration of Day 28) [ Time Frame: up to 672 hours ]
- Cmax,28 (maximum measured concentration of the analyte in plasma following administration of Day 28) [ Time Frame: up to 672 hours ]
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Estimated Enrollment: |
48 |
| 1 |
Actual Study Start Date: |
June 7, 2017 |
| 2 |
Estimated Study Completion Date: |
December 17, 2017 |
| 3 |
Estimated Primary Completion Date: |
December 3, 2017 (Final data collection date for primary outcome measure) |
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Arms |
Assigned Interventions |
| 1 |
Experimental: BI 1467335 |
Drug: BI 1467335Duration - 28 days |
| 2 |
Placebo Comparator: Placebo |
Drug: PlaceboDuration - 28 days |
