NCT01900171

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
Last Updated

July 16, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

June 26, 2013

Last Update Submit

July 11, 2013

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (32)

  • Adverse events

    up to 11 days

  • Blood pressure

    up to 11 days

  • Heart rate

    up to 11 days

  • Body temperature

    up to 11 days

  • 12-lead ECG

    up to 11 days

  • Red blood cell count

    up to 11 days

  • Haemoglobin

    up to 11 days

  • Haematocrit

    up to 11 days

  • White blood cell count with differential

    up to 11 days

  • Platelet count

    up to 11 days

  • Plasma sodium

    up to 11 days

  • Plasma potassium

    up to 11 days

  • Plasma calcium

    up to 11 days

  • Plasma total bilirubin

    up to 11 days

  • Plasma conjugated bilirubin

    up to 11 days

  • Plasma Aspartate Amino Transferase (ASAT)

    up to 11 days

  • Plasma Alanine Amino Transferase (ALAT)

    up to 11 days

  • Plasma Gamma Glutamyl Transferase (GGT)

    up to 11 days

  • Plasma alkaline phosphatases

    up to 11 days

  • Plasma total protein

    up to 11 days

  • Plasma Creatine PhosphoKinase (CPK)

    up to 11 days

  • Plasma creatinine

    up to 11 days

  • Plasma glucose

    up to 11 days

  • Plasma cholesterol

    up to 11 days

  • Plasma triglycerides

    up to 11 days

  • Urinary pH

    up to 11 days

  • Urinary protein

    up to 11 days

  • Urinary glucose

    up to 11 days

  • Urinary leukocytes

    up to 11 days

  • Urinary nitrites

    up to 11 days

  • Urinary ketones

    up to 11 days

  • Urinary blood

    up to 11 days

Secondary Outcomes (17)

  • Maximum observed plasma concentration (Cmax) of QGC001

    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

    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

    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

    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

    H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose

  • +12 more secondary outcomes

Study Arms (9)

10 mg of QGC001

EXPERIMENTAL

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)]

50 mg of QGC001

EXPERIMENTAL

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)]

125 mg of QGC001

EXPERIMENTAL

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)]

250 mg of QGC001

EXPERIMENTAL

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)]

500 mg of QGC001

EXPERIMENTAL

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)]

750 mg of QGC001

EXPERIMENTAL

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)]

1,000 mg of QGC001

EXPERIMENTAL

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)]

1,250 mg of QGC001

EXPERIMENTAL

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

PLACEBO COMPARATOR

The placebo was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1.

Drug: Placebo

Interventions

QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]DRUG
1,000 mg of QGC0011,250 mg of QGC00110 mg of QGC001125 mg of QGC001250 mg of QGC00150 mg of QGC001500 mg of QGC001750 mg of QGC001
PlaceboDRUG

Contains magnesium stearate, silica dental type, anhydrous lactose

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biotrial PARIS

Rueil-Malmaison, 92502, France

Location

Related Publications (1)

  • 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.

    PMID: 33027067DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 16, 2013

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 16, 2013

Record last verified: 2013-07

Locations

FR(1)