At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
PBTZ169 640 mg OD +4 moredrug
Likely dose
PBTZ169 640 mg ODfrom 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.
An Open-label, Prospective Study of Safety, Tolerability, Pharmacokinetics and Food Effects of PBTZ169, 80 mg Capsules, When Used in Ascending Doses in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating PBTZ169 640 mg OD, PBTZ169 640 mg BiD, and 3 other interventions for Healthy Subjects. Completed, enrolled 60 participants across 1 site.
Detailed Summary
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
CountriesRussia
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartJul 2018
Primary CompletionNov 2018
Study CompletionFeb 2019
First PostedNov 2019
TodayJul 2026
First PostedNov 4, 2019
Enrollment StartJul 3, 2018
Primary CompletionNov 23, 2018
Study CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.7 years ago
Interventions
PBTZ169 640 mg ODdrug
Two administrations once a day with a wash-out period: food effect
PBTZ169 640 mg BiDdrug
Twice a day fasted; 1 day of administration
PBTZ169 960 mg SDdrug
Once a day fasted
PBTZ169 1280 mg SDdrug
Once a day fasted
PBTZ169 1280 mg MDdrug
Once a day after meal, 14 doses