NCT04150224View on ClinicalTrials.gov

Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 3, 2018

Primary Completion Date

November 23, 2018

Study Completion Date

February 1, 2019

Conditions
Healthy Subjects
Interventions
DRUG

PBTZ169 640 mg OD

Two administrations once a day with a wash-out period: food effect

DRUG

PBTZ169 640 mg BiD

Twice a day fasted; 1 day of administration

DRUG

PBTZ169 960 mg SD

Once a day fasted

DRUG

PBTZ169 1280 mg SD

Once a day fasted

DRUG

PBTZ169 1280 mg MD

Once a day after meal, 14 doses

Trial Locations (1)

150030

Clinical hospital at the Yaroslavl station of the Open Joint Stock Company Russian Railways, Yaroslavl

All Listed Sponsors
lead

Nearmedic Plus LLC

INDUSTRY

NCT04150224 - Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169 | Biotech Hunter | Biotech Hunter