Essential HypertensionPhase 1NCT01900184
Study of the Product QGC001 as a Single Dose and Multiple Doses Administered Orally to Healthy Adult Subjects
A Phase 1 study testing QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] in people with Essential Hypertension, run by Quantum Genomics SA at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Part 1: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Ascending Single Dose and Food Influence Study of QGC001 Administered Orally To Healthy Adult Subjects, Part 2: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Ascending Multiple Dose Study of QGC001 Administered Orally To Healthy Adult Subjects.
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.
- Conditions
- Essential Hypertension
- Being tested
- QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)], Placebo
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Drug
PlaceboDrug
Contains magnesium stearate, silica dental type, anhydrous lactose
| Study group | Role | What they receive |
|---|---|---|
| 500 mg bid of QGC001 | Experimental | Each dose of QGC001 will be administered in solution with 200 mL of purified water. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| 750 mg bid of QGC001 | Experimental | Each dose of QGC001 will be administered in solution with 200 mL of purified water. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| 1,000 mg bid of QGC001 | Experimental | Each dose of QGC001 will be administered in solution with 200 mL of purified water. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| Placebo | Placebo comparator | The placebo will be administered in solution with 200 mL of purified water. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Red blood cell count
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Haemoglobin
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Haematocrit
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
White blood cell count with differential
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Platelet count
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma sodium
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma potassium
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma calcium
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma total bilirubin
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma conjugated bilirubin
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma Aspartate Amino Transferase (ASAT)
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma Alanine Amino Transferase (ALAT)
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma Gamma Glutamyl Transferase (GGT)
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma alkaline phosphatases
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma total protein
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma Creatine PhosphoKinase (CPK)
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma creatinine
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma glucose
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma cholesterol
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma triglycerides
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary pH
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary protein
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary glucose
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary leukocytes
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary nitrites
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary ketones
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary blood
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Weight assessment (kg)
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Body temperature (°C)
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Supine and orthostatic (systolic and diastolic) blood pressure
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Heart rate
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
12-lead ECG
Measured: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Secondary outcomes (21)
Maximum observed plasma concentration (Cmax) of QGC001
Cohorts SAD 1 to 4 and MAD 1 to 3.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Fraction recovered (Fe)
Cohorts SAD 1 to 4 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Renal clearance (CLR)
Cohorts SAD 1 to 4 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Plasma renin
Determination of renin in blood samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Plasma aldosterone
Determination of aldosterone in blood samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Plasma cortisol
Determination of cortisol in blood samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Plasma copeptin
Determination of copeptin in blood samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary aldosterone
Aldosterone analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary cortisol
Cortisol analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary sodium
Sodium analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary potassium
Potassium analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary creatinine
Creatinine analysis in urine samples. Cohorts SAD 1 to 3 and MAD 1 to 3.
Measured: up to 2 days for SAD and FI, up to 8 days for MAD
Systolic and Diastolic Blood Pressure
Cohorts MAD 1 to 3.
Measured: up to 8 days for MAD
Heart Rate
Cohorts MAD 1 to 3.
Measured: up to 8 days for MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Genomics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900184
- Sponsor's protocol ID
- QGC001/1QG2
- Status last verified
- Jul 2013
- First submitted
- 27 Jun 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.
PubMed 33027067
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Part 1: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Ascending Single Dose and Food Influence Study of QGC001 Administered Orally To Healthy Adult Subjects, Part 2: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Ascending Multiple Dose Study of QGC001 Administered Orally To Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT01900184
- Acronym / sponsor ID
- QGC001/1QG2
- Conditions
- Essential Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Quantum Genomics SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 500 mg bid of QGC001 | Experimental | Drug: 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 | Experimental | Drug: 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 | Experimental | Drug: 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 comparator | Drug: PlaceboThe placebo will be administered in solution with 200 mL of purified water. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] | Drug | 1,000 mg bid of QGC001, 500 mg bid of QGC001, 750 mg bid of QGC001 |
| PlaceboContains magnesium stearate, silica dental type, anhydrous lactose | Drug | Placebo |
Primary outcome
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)
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma Alanine Amino Transferase (ALAT)
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma Gamma Glutamyl Transferase (GGT)
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma alkaline phosphatases
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma total protein
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma Creatine PhosphoKinase (CPK)
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma creatinine
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma glucose
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma cholesterol
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Plasma triglycerides
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary pH
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary protein
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary glucose
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary leukocytes
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary nitrites
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary ketones
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Urinary blood
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Weight assessment (kg)
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Body temperature (°C)
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Supine and orthostatic (systolic and diastolic) blood pressure
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
Heart rate
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
12-lead ECG
Time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD
21 secondary outcomes
Maximum observed plasma concentration (Cmax) of QGC001
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
Time frame: up to 3 days for SAD and FI, up to 9 days for MAD
Elimination rate constant (λz) of QGC001
Time frame: up to 3 days for SAD and FI, up to 9 days for MAD
Terminal half-life (t1/2,z) of QGC001
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
Time frame: up to 3 days for SAD and FI, up to 9 days for MAD
Maximum observed plasma concentration (MRCmax) of metabolic ratios
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
Time frame: up to 3 days for SAD and FI, up to 9 days for MAD
Cumulative amount eliminated (Ae)
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Fraction recovered (Fe)
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Renal clearance (CLR)
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Plasma renin
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Plasma aldosterone
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Plasma cortisol
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Plasma copeptin
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary aldosterone
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary cortisol
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary sodium
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary potassium
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Urinary creatinine
Time frame: up to 2 days for SAD and FI, up to 8 days for MAD
Systolic and Diastolic Blood Pressure
Time frame: up to 8 days for MAD
Heart Rate
Time frame: up to 8 days for MAD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
- Derived from this study: PubMed 33027067Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] in people with Essential Hypertension, run by Quantum Genomics SA at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: up to 4 weeks for SAD, 5 weeks for FI and 6 weeks for MAD). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01900184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.