Study of the Product QGC001 as a Single Dose and Multiple Doses Administered Orally to Healthy Adult Subjects
Phase 1
Completed
- Conditions
- Essential Hypertension
- Interventions
- Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Drug: Placebo
- Registration Number
- NCT01900184
- Lead Sponsor
- Quantum Genomics SA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 69
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 500 mg bid of QGC001 QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] Each dose of QGC001 will be administered in solution with 200 mL of purified water. 750 mg bid of QGC001 QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] Each dose of QGC001 will be administered in solution with 200 mL of purified water. 1,000 mg bid of QGC001 QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] Each dose of QGC001 will be administered in solution with 200 mL of purified water. Placebo Placebo The placebo will be administered in solution with 200 mL of purified water.
- Primary Outcome Measures
Name Time Method Adverse events up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Red blood cell count up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Haemoglobin up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Haematocrit up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD White blood cell count with differential up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Platelet count up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma sodium up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma potassium up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma calcium up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma total bilirubin up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma conjugated bilirubin up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma Aspartate Amino Transferase (ASAT) up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma Alanine Amino Transferase (ALAT) up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma Gamma Glutamyl Transferase (GGT) up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma alkaline phosphatases up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma total protein up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma Creatine PhosphoKinase (CPK) up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma creatinine up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma glucose up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma cholesterol up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Plasma triglycerides up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Urinary pH up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Urinary protein up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Urinary glucose up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Urinary leukocytes up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Urinary nitrites up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Urinary ketones up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Urinary blood up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Weight assessment (kg) up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Body temperature (°C) up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Supine and orthostatic (systolic and diastolic) blood pressure up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD Heart rate up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD 12-lead ECG up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
- Secondary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) of QGC001 up to 3 days for SAD and FI, up to 9 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Time at which Cmax is observed (tmax) of QGC001 up to 3 days for SAD and FI, up to 9 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Elimination rate constant (λz) of QGC001 up to 3 days for SAD and FI, up to 9 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Terminal half-life (t1/2,z) of QGC001 up to 3 days for SAD and FI, up to 9 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Area Under the Concentration-time curve (AUClast and AUC0-∞) of QGC001 up to 3 days for SAD and FI, up to 9 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Maximum observed plasma concentration (MRCmax) of metabolic ratios up to 3 days for SAD and FI, up to 9 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Area Under the Concentration-time curve (MRAUC) of metabolic ratios up to 3 days for SAD and FI, up to 9 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Cumulative amount eliminated (Ae) up to 2 days for SAD and FI, up to 8 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Fraction recovered (Fe) up to 2 days for SAD and FI, up to 8 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Renal clearance (CLR) up to 2 days for SAD and FI, up to 8 days for MAD Cohorts SAD 1 to 4 and MAD 1 to 3.
Plasma renin up to 2 days for SAD and FI, up to 8 days for MAD Determination of renin in blood samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Plasma aldosterone up to 2 days for SAD and FI, up to 8 days for MAD Determination of aldosterone in blood samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Plasma cortisol up to 2 days for SAD and FI, up to 8 days for MAD Determination of cortisol in blood samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Plasma copeptin up to 2 days for SAD and FI, up to 8 days for MAD Determination of copeptin in blood samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Urinary aldosterone up to 2 days for SAD and FI, up to 8 days for MAD Aldosterone analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Urinary cortisol up to 2 days for SAD and FI, up to 8 days for MAD Cortisol analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Urinary sodium up to 2 days for SAD and FI, up to 8 days for MAD Sodium analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Urinary potassium up to 2 days for SAD and FI, up to 8 days for MAD Potassium analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Urinary creatinine up to 2 days for SAD and FI, up to 8 days for MAD Creatinine analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Systolic and Diastolic Blood Pressure up to 8 days for MAD Cohorts MAD 1 to 3.
Heart Rate up to 8 days for MAD Cohorts MAD 1 to 3.
Trial Locations
- Locations (1)
Biotrial PARIS
🇫🇷Rueil-Malmaison, France