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

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03694041
• Other study ID #: OP101817.APT
• Secondary ID: 2017-004252-30
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2018
• Est. completion date: March 6, 2019

Study information

• Verified date: March 2019
• Source: Aptabio Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 6, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Safety

Intervention

Drug:
• SAD: APX-115
Drug: APX-115 SAD APX-115 SAD for 1day
• SAD: Placebo
Drug: Placebo Placebo for 1day
• MAD: APX-115
Drug: APX-115 MAD APX-115 MAD repeatedly administered.
• 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.
• Metabolic probe with or without APX-115
A metabolic probe will be administered with and without APX-115.

Locations

Country	Name	City	State
France	Eurofins Optimed	Gières

Sponsors (1)

Lead Sponsor	Collaborator
Aptabio Therapeutics, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAD: incidence of treatment emergent adverse events		Up to Day 8
Primary	SAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)		Up to Day 8
Primary	SAD: number of clinically significant abnormal findings from physical exam		Up to Day 8
Primary	SAD: number of clinically significant abnormal findings from electrocardiogram		Up to Day 8
Primary	SAD: number of clinically significant abnormal findings from biological tests		Up to Day 8
Primary	MAD: incidence of treatment emergent adverse events		Up to Day 17
Primary	MAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)		Up to Day 17
Primary	MAD: number of clinically significant abnormal findings from physical exams		Up to Day 17
Primary	MAD: number of clinically significant abnormal findings from electrocardiogram		Up to Day 17
Primary	Food effect: peak serum concentration (Cmax) of APX-115 under fasting and fed conditions		Up to Day 4 post-dose
Primary	Food effect: time to reach the Cmax (Tmax) of APX-115 under fasting and fed conditions		Up to Day 4 post-dose
Primary	Food effect: area under the curve (AUC) of APX-115 under fasting and fed conditions		Up to Day 4 post-dose
Primary	Food effect: elimination rate constant (Kel) of APX-115 under fasting and fed conditions		Up to Day 4 post-dose
Primary	Food effect: ratio AUCfed/AUCfasted		Up to Day 4 post-dose
Primary	Drug interaction: peak serum concentration (Cmax) of a metabolic probe or APX-115		Up to Day 4 post-dose
Primary	Drug interaction: Time to reach the Cmax (tmax) of a metabolic probe or APX-115		Up to Day 4 post-dose
Primary	Drug interaction study: Area under the Curve (AUC) of a metabolic probe or APX-115		Up to Day 4 post-dose
Primary	Drug interaction: elimination rate constant (Kel) of a metabolic probe or APX-115		Up to Day 4 post-dose
Primary	Drug interaction: half-life (t1/2) of a metabolic probe or APX-115		Up to Day 4 post-dose
Primary	Drug interaction: volume of distribution (Vd/f) of a metabolic probe or APX-115		Up to Day 4 post-dose
Primary	Drug interaction: clearance of a metabolic probe or APX-115		Up to Day 4 post-dose
Primary	Drug interaction: Incidences of treatment emergent adverse events		Up to Day 4 post-dose
Secondary	SAD: time to reach Cmax (Tmax) of APX-115		Up to Day 5
Secondary	SAD: peak serum concentration (Cmax) of APX-115		Up to Day 5
Secondary	SAD: lowest plasma concentration before next dosing (Ctrough)		Up to Day 5
Secondary	SAD: Area Under the Curve (AUC) of APX-115		Up to Day 5
Secondary	SAD: volume of distribution (Vd/F) of APX-115		Up to Day 5
Secondary	SAD: clearance (CL/F) of APX-115		Up to Day 5
Secondary	MAD: peak serum concentration (Cmax) of APX-115		Up to Day 11
Secondary	MAD: time to reach the Cmax (Tmax) of APX-115		Up to Day 11
Secondary	MAD: Area Under the Curve (AUC) of APX-115		Up to Day 11
Secondary	MAD: lowest plasma concentration of APX-115 before next dosing (Ctrough)		Up to Day 11
Secondary	MAD: volume of distribution (Vd/F) of APX-115		Up to Day 11
Secondary	MAD: Clearance (CL/F) of APX-115		Up to Day 11
Secondary	MAD: accumulation ratio		Up to Day 11
Secondary	Food effect & drug interaction: incidence of treatment emergent adverse events		Up to Day 4 post-dose
Secondary	Food effect & drug interaction: number of clinically significant findings from vital signs (blood pressure and pulse)		Up to Day 4 post-dose
Secondary	Food effect & drug interaction: number of clinically significant findings from physical exam		Up to Day 4 post-dose
Secondary	Food effect & drug interaction: number of clinically significant findings from electrocardiogram		Up to Day 4 post-dose
Secondary	Food effect & drug interaction: number of clinically significant findings from biological tests		Up to Day 4 post-dose