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

NCT03694041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2019-03-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Aptabio Therapeutics, Inc.

    lead INDIV

Principal Investigators

  • Yves Donazzolo, MD · Eurofins Optimed

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2019-03-06
Completion
2019-03-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694041 on ClinicalTrials.gov