Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers
NCT ID: NCT03694041
Last Updated: 2019-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
88 participants
INTERVENTIONAL
2018-05-28
2019-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SAD: APX-115
Experimental: APX-115 SAD group
SAD: APX-115
Drug: APX-115 SAD APX-115 SAD for 1day
SAD: Placebo
Experimental: Placebo group
SAD: Placebo
Drug: Placebo Placebo for 1day
MAD: APX-115
Experimental: APX-115 MAD group
MAD: APX-115
Drug: APX-115 MAD APX-115 MAD repeatedly administered.
MAD: Placebo
Experimental: Placebo group
MAD: Placebo
Matching study drug will be repeatedly administered.
Food effect - Fasting condition
Experimental: APX-115 under fasting condition
Food effect: fasted and fed
A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.
Food effect - fed condition
Experimental: APX-115 under fed condition
Food effect: fasted and fed
A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.
Drug Interaction - metabolic probe
Experimental: metabolic probe
Metabolic probe with or without APX-115
A metabolic probe will be administered with and without APX-115.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Aptabio Therapeutics, Inc.
INDIV
Responsible Party
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Principal Investigators
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Yves Donazzolo, MD
Role: PRINCIPAL_INVESTIGATOR
Eurofins Optimed
Locations
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Eurofins Optimed
Gières, , France
Countries
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Other Identifiers
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2017-004252-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OP101817.APT
Identifier Type: -
Identifier Source: org_study_id
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