At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
BDM-2 in Bottle (50 mg - 3600 mg); oral suspensiondrug
Likely dose
BDM-2 in Bottle (50 mg - 3600 mg); oral suspensionfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Ascending Dose Trial Investigating the Safety, Tolerability and Pharmacokinetics of Orally Administered BDM-2 in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating BDM-2 in Bottle (50 mg - 3600 mg); oral suspension for Healthy. Completed, enrolled 16 participants across 1 site.
Detailed Summary
This is a first-in-human (FIH), double-blind, placebo-controlled, randomized trial in healthy adult male subjects, to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of BDM-2. The effect of food on the PK of a single dose of BDM-2 will also be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
CollaboratorsVenn Life Sciences
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
Primary CompletionAug 2018
First PostedAug 2018
Study CompletionAug 2018
TodayJul 2026
First PostedAug 16, 2018
Enrollment StartMay 17, 2018
Primary CompletionAug 13, 2018
Study CompletionAug 28, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.9 years ago
Interventions
BDM-2 in Bottle (50 mg - 3600 mg); oral suspensiondrug
BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.