Study of the Product QGC001 as a Single Dose and Multiple Doses Administered Orally to Healthy Adult Subjects

Phase 1CompletedNCT01900184

Quantum Genomics SA69 enrolled

Overview

1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending single/multiple oral doses (SAD \& MAD) in healthy young subjects, the preliminary food interaction and the effect of QGC001 on blood pressure and heart rate, but also to determine pharmacokinetic preliminary profiles of QGC001 and its metabolite EC33 and pharmacodynamic preliminary profiles of QGC001 and its metabolite EC33 especially effects on the renin-angiotensin-aldosterone and copeptin systems.

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 (inclusive). * 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 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Red blood cell count

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Haemoglobin

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Haematocrit

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

White blood cell count with differential

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Platelet count

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Plasma sodium

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Plasma potassium

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Plasma calcium

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Plasma total bilirubin

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Plasma conjugated bilirubin

Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD

Plasma Aspartate Amino Transferase (ASAT)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Maximum observed plasma concentration (Cmax) of QGC001

Cohorts SAD 1 to 4 and MAD 1 to 3.

Time frame: up to 3 days for SAD and FI, up to 9 days for MAD

Time at which Cmax is observed (tmax) of QGC001

Cohorts SAD 1 to 4 and MAD 1 to 3.

Time frame: up to 3 days for SAD and FI, up to 9 days for MAD

Elimination rate constant (λz) of QGC001

Cohorts SAD 1 to 4 and MAD 1 to 3.

Time frame: up to 3 days for SAD and FI, up to 9 days for MAD

Terminal half-life (t1/2,z) of QGC001

Cohorts SAD 1 to 4 and MAD 1 to 3.

Time frame: up to 3 days for SAD and FI, up to 9 days for MAD

Area Under the Concentration-time curve (AUClast and AUC0-∞) of QGC001

Cohorts SAD 1 to 4 and MAD 1 to 3.

Time frame: up to 3 days for SAD and FI, up to 9 days for MAD

Maximum observed plasma concentration (MRCmax) of metabolic ratios

Cohorts SAD 1 to 4 and MAD 1 to 3.

Time frame: up to 3 days for SAD and FI, up to 9 days for MAD

Area Under the Concentration-time curve (MRAUC) of metabolic ratios

Cohorts SAD 1 to 4 and MAD 1 to 3.

Time frame: up to 3 days for SAD and FI, up to 9 days for MAD

Cumulative amount eliminated (Ae)

Cohorts SAD 1 to 4 and MAD 1 to 3.