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

Aptabio Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy; Safety

Treatments: Other: Food effect: fasted and fed; Drug: SAD: Placebo; Other: Metabolic probe with or without APX-115; Drug: SAD: APX-115; Drug: MAD: Placebo; Drug: MAD: APX-115

Study type: Interventional

Identifiers

NCT03694041

2017-004252-30 (EudraCT Number)

OP101817.APT

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 7 patient groups, including a placebo group

SAD: APX-115

Experimental group

Description:

Experimental: APX-115 SAD group

Treatment:

Drug: SAD: APX-115

SAD: Placebo

Placebo Comparator group

Description:

Experimental: Placebo group

Treatment:

Drug: SAD: Placebo

MAD: APX-115

Experimental group

Description:

Experimental: APX-115 MAD group

Treatment:

Drug: MAD: APX-115

MAD: Placebo

Placebo Comparator group

Description:

Experimental: Placebo group

Treatment:

Drug: MAD: Placebo

Food effect - Fasting condition

Active Comparator group

Description:

Experimental: APX-115 under fasting condition

Treatment:

Other: Food effect: fasted and fed

Food effect - fed condition

Active Comparator group

Description:

Experimental: APX-115 under fed condition

Treatment:

Other: Food effect: fasted and fed

Drug Interaction - metabolic probe

Placebo Comparator group

Description:

Experimental: metabolic probe

Treatment:

Other: Metabolic probe with or without APX-115