Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo

July 11, 2013 updated by: Quantum Genomics SA

A Phase I, Double-blind, Placebo-controlled, Ascending Single-dose, Safety, Tolerability and Pharmacokinetic Study of QGC001 in Healthy Male Subjects.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rueil-Malmaison, France, 92502
        • Biotrial PARIS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 10 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
Experimental: 50 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
Experimental: 125 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
Experimental: 250 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
Experimental: 500 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
Experimental: 750 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
Experimental: 1,000 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
Experimental: 1,250 mg of QGC001
Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
Placebo Comparator: Placebo
The placebo was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.
Drug: Placebo
Contains magnesium stearate, silica dental type, anhydrous lactose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse events
Time Frame: up to 11 days
up to 11 days
Blood pressure
Time Frame: up to 11 days
up to 11 days
Heart rate
Time Frame: up to 11 days
up to 11 days
Body temperature
Time Frame: up to 11 days
up to 11 days
12-lead ECG
Time Frame: up to 11 days
up to 11 days
Red blood cell count
Time Frame: up to 11 days
up to 11 days
Haemoglobin
Time Frame: up to 11 days
up to 11 days
Haematocrit
Time Frame: up to 11 days
up to 11 days
White blood cell count with differential
Time Frame: up to 11 days
up to 11 days
Platelet count
Time Frame: up to 11 days
up to 11 days
Plasma sodium
Time Frame: up to 11 days
up to 11 days
Plasma potassium
Time Frame: up to 11 days
up to 11 days
Plasma calcium
Time Frame: up to 11 days
up to 11 days
Plasma total bilirubin
Time Frame: up to 11 days
up to 11 days
Plasma conjugated bilirubin
Time Frame: up to 11 days
up to 11 days
Plasma Aspartate Amino Transferase (ASAT)
Time Frame: up to 11 days
up to 11 days
Plasma Alanine Amino Transferase (ALAT)
Time Frame: up to 11 days
up to 11 days
Plasma Gamma Glutamyl Transferase (GGT)
Time Frame: up to 11 days
up to 11 days
Plasma alkaline phosphatases
Time Frame: up to 11 days
up to 11 days
Plasma total protein
Time Frame: up to 11 days
up to 11 days
Plasma Creatine PhosphoKinase (CPK)
Time Frame: up to 11 days
up to 11 days
Plasma creatinine
Time Frame: up to 11 days
up to 11 days
Plasma glucose
Time Frame: up to 11 days
up to 11 days
Plasma cholesterol
Time Frame: up to 11 days
up to 11 days
Plasma triglycerides
Time Frame: up to 11 days
up to 11 days
Urinary pH
Time Frame: up to 11 days
up to 11 days
Urinary protein
Time Frame: up to 11 days
up to 11 days
Urinary glucose
Time Frame: up to 11 days
up to 11 days
Urinary leukocytes
Time Frame: up to 11 days
up to 11 days
Urinary nitrites
Time Frame: up to 11 days
up to 11 days
Urinary ketones
Time Frame: up to 11 days
up to 11 days
Urinary blood
Time Frame: up to 11 days
up to 11 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax) of QGC001
Time Frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Time at which Cmax is observed (tmax) of QGC001
Time Frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Elimination rate constant (λz) of QGC001
Time Frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Terminal half-life (t1/2,z) of QGC001
Time Frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Area Under the Concentration-time curve (AUClast and AUC0-∞) of QGC001
Time Frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Maximum observed plasma concentration (MRCmax) of metabolic ratios
Time Frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Area Under the Concentration-time curve (MRAUC) of metabolic ratios
Time Frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Cumulative amount eliminated (Ae)
Time Frame: H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
Fraction recovered (Fe)
Time Frame: H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
Renal clearance (CLR)
Time Frame: H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
Plasma renin
Time Frame: H-1 pre-dose and H2, H4 and H9 post-dose
Determination of renin in blood samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
H-1 pre-dose and H2, H4 and H9 post-dose
Plasma aldosterone
Time Frame: H-1 pre-dose and H2, H4 and H9 post-dose
Determination of aldosterone in blood samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
H-1 pre-dose and H2, H4 and H9 post-dose
Plasma cortisol
Time Frame: H-1 pre-dose and H2, H4 and H9 post-dose
Determination of cortisol in blood samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
H-1 pre-dose and H2, H4 and H9 post-dose
Plasma copeptin
Time Frame: H-1 pre-dose and H2, H4 and H9 post-dose
Determination of copeptin in blood samples (if possible, will be determined later). In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
H-1 pre-dose and H2, H4 and H9 post-dose
Urinary aldosterone
Time Frame: H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Aldosterone analysis in urine samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Urinary cortisol
Time Frame: H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Cortisol analysis in urine samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Urinary creatinin
Time Frame: H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Creatinin analysis in urine samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Quantum Genomics SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QGC001/1QG1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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