Trial | NCT03694041  Report issue

Title

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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    88
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.
Study Started
May 28
2018
Primary Completion
Mar 06
2019
Study Completion
Mar 06
2019
Last Update
Mar 11
2019

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.

SAD: APX-115 Experimental

Experimental: APX-115 SAD group

SAD: Placebo Placebo Comparator

Experimental: Placebo group

MAD: APX-115 Experimental

Experimental: APX-115 MAD group

MAD: Placebo Placebo Comparator

Experimental: Placebo group

Food effect - Fasting condition Active Comparator

Experimental: APX-115 under fasting condition

Food effect - fed condition Active Comparator

Experimental: APX-115 under fed condition

Drug Interaction - metabolic probe Placebo Comparator

Experimental: metabolic probe

Criteria 

Inclusion:

Healthy male subject, aged between 18 and 45 years inclusive
Certified as healthy by a comprehensive clinical assessment
Normal dietary habits
Normal ECG recording on a 12-lead ECG
Signing a written informed consent prior to selection

Exclusion:

Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease
Frequent headaches and / or migraine, recurrent nausea and / or vomiting
Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position
Blood donation (including in the frame of a clinical trial) within 2 months before administration
General anaesthesia within 3 months before administration
Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician
Inability to abstain from intensive muscular effort
No possibility of contact in case of emergency
Any drug intake (except paracetamol or contraception) during the last month prior to the first administration
History or presence of drug or alcohol abuse (alcohol consumption > 30 grams / day)
Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day)
Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
Positive results of screening for drugs of abuse
Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
Administrative or legal supervision
No Results Posted