Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo

Phase 1CompletedNCT01900171

Quantum Genomics SA56 enrolled

Overview

QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Essential Hypertension

Interventions

QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]DRUG

PlaceboDRUG

Contains magnesium stearate, silica dental type, anhydrous lactose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Caucasian, male healthy subjects of 18 to 45 years of age. * Body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening. * Subjects will sign and date an informed consent form before any study-specific screening procedure is performed. * Healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings. * Non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. * Have a high probability for compliance with and completion of the study. Exclusion Criteria: * Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy. * Acute disease state within 7 days before study day 1. * History of drug abuse within 1 year before study day 1. * History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day. * Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies. * Positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA) * History of any clinically important drug allergy. * Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration. * Consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1. * Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration. * Donation of blood (i.e. 450 ml) within 90 days before study day 1.

Locations (1)

Biotrial PARIS

Rueil-Malmaison, France

Outcomes

Primary Outcomes

Adverse events

Time frame: up to 11 days

Blood pressure

Time frame: up to 11 days

Heart rate

Time frame: up to 11 days

Body temperature

Time frame: up to 11 days

12-lead ECG

Time frame: up to 11 days

Red blood cell count

Time frame: up to 11 days

Haemoglobin

Time frame: up to 11 days

Haematocrit

Time frame: up to 11 days

White blood cell count with differential

Time frame: up to 11 days

Platelet count

Time frame: up to 11 days

Plasma sodium

Time frame: up to 11 days

Plasma potassium

Time frame: up to 11 days

Plasma calcium

Time frame: up to 11 days

Plasma total bilirubin

Time frame: up to 11 days

Data from ClinicalTrials.gov

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