Essential Hypertension
Conditions
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.
Interventions
DRUGPlacebo
Contains magnesium stearate, silica dental type, anhydrous lactose
Sponsors
Quantum Genomics SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-lead ECG | 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 |
| 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
France
Outcome results
None listed