NCT03694041

Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers

Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses or Multiple Ascending Doses of APX-115 in Healthy Male Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Aptabio Therapeutics, Inc. · Individual
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males.

Conditions

• Healthy
• Safety

Interventions

Type	Name	Description
DRUG	SAD: APX-115	Drug: APX-115 SAD APX-115 SAD for 1day
DRUG	SAD: Placebo	Drug: Placebo Placebo for 1day
DRUG	MAD: APX-115	Drug: APX-115 MAD APX-115 MAD repeatedly administered.
DRUG	MAD: Placebo	Matching study drug will be repeatedly administered.
OTHER	Food effect: fasted and fed	A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.
OTHER	Metabolic probe with or without APX-115	A metabolic probe will be administered with and without APX-115.

Timeline

• Start date: 2018-05-28
• Primary completion: 2019-03-06
• Completion: 2019-03-06
• First posted: 2018-10-03
• Last updated: 2019-03-11

Locations

1 site across 1 country: France