- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02370043
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect of KQ-791
Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of KQ-791 in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Quebec, Canada, G1P 0A2
- inVentiv
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Quebec
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Montreal, Quebec, Canada, H3X 2Hp
- inVentiv
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or non-childbearing potential female, which includes post-menopausal female (absence of menses for 12 months prior to drug administration, bilateral oophorectomy or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration) or surgically sterile female (hysterectomy or tubal ligation at least 6 months prior to drug administration)
- Body Mass Index (BMI) greater than or equal to (≥) 27.0 and less than or equal to (≤) 35.0 kilogram per square meter (kg/m2)
Healthy as defined by:
- absence of clinically significant illness and surgery within last 4 weeks. Participants vomiting within 24 hours pre-dose will be evaluated for upcoming illness/disease
- the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, or metabolic disease
Male participants who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner (sterile female partners include post-menopausal females and surgically sterile females) must be willing to use one of the following acceptable contraceptive methods throughout the study and for 90 days after the last study drug administration:
- simultaneous use of a condom, and for the female partner hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks)
- simultaneous use of a male condom, and for his female partner, a diaphragm with intravaginally applied spermicide
Some degree of insulin resistance, as shown by:
- fasting blood glucose ≥95.4 and ≤126 milligrams per deciliter (mg/dL) (equivalent to 5.3 to 7.0 millimoles per liter (mmol/L), respectively) and
- fasting triglycerides ≤ 4.0 mmol/L, and/or
- Low-Density Lipoprotein Cholesterol (LDL-C) ≤ 6.0 mmol/L
- Capable of consent
- Non-smoker (no use of tobacco products within the last 3 months)
Exclusion Criteria:
- Any clinically significant abnormality or abnormal laboratory test results (other than glucose,triglycerides and LDL-C levels described in inclusion criterion)
- Positive test for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV)
- Evidence of clinically significant hepatic or renal impairment, including Alanine Aminotransferase (ALT) above 1.5x Upper Limit of Normal (ULN), Aspartate Aminotransferase (AST) above 2x ULN, total bilirubin above 2x ULN (total bilirubin accepted up to 2x ULN if direct bilirubin is within normal limits), or Estimated Glomerular Filtration Rate (eGFR) less than (<) 90 milliliters per minute (mL/minute)
- Positive urine drug screen
- History of significant allergic reactions (e.g. angioedema) to any drug.
- Use of any drugs known to induce or inhibit hepatic drug metabolism within the last 30 days
- Positive pregnancy test
- Any reason which, in the opinion of the qualified investigator (QI) would prevent the subject from participating in the study
Clinically significant electrocardiogram (ECG) abnormalities at screening, or clinically significant personal or family history (in a first-degree relative) of heart diseases, including:
- Confirmed corrected QT (QTcF) interval greater than (>) 450 milliseconds (msec) for men and women
- Bundle branch blocks and other conduction abnormalities other than mild first degree atrio-ventricular block
- Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
- History of unexplained syncope
- Family history of unexplained sudden death or sudden death due to long QT syndrome
- T-wave configurations are not of sufficient quality for assessing QT interval
- Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 150 mmHg, diastolic blood pressure lower than 50 or over 95 mmHg, or heart rate less than 50 or over 100 beats per minute (bpm))
- History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening (regular use of more than three units of alcohol per day for males and more than two units of alcohol per day for females [1 unit = 150 (milliliter) mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) or positive alcohol breath test
- History of significant drug abuse within the last year or use of soft drugs (such as marijuana) within 3 months prior, or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within the last year
- Participation in a clinical trial involving the administration of an investigational or marketed drug within the last 30 days (90 days for biologics) or concomitant participation in an investigational study
Use of medication other than topical products without significant systemic absorption:
- prescription medication within last 14 days
- over-the-counter products within the last 7 days, with the exception of the occasional use of acetaminophen (up to 2 grams (g) daily)
- natural health products (e.g. food supplements or herbal supplements) within last 14 days
- a depot injection or an implant of any drug within last 3 months
- Donation of plasma within the last 7 days. Donation or loss of blood of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days
- Hemoglobin <128 grams per liter (g/L) (males) and <115 g/L (females) and hematocrit <0.37 L/L (males) and <0.32 L/L (females)
- Breast-feeding participant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: KQ-791
Escalating doses of KQ-791, starting at 15 milligrams
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Capsules administered orally while fasting, in up to 3 periods
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Experimental: KQ-791 (after meal)
Single dose of KQ-791 in capsule form, after a meal
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Single dose of KQ-791 in capsules, after a meal, in 1 period
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Placebo Comparator: Placebo
Single dose of placebo matching KQ-791 dose
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Capsules, administered orally, in 1 period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug
Time Frame: Baseline to study completion (up to 11 weeks)
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Baseline to study completion (up to 11 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
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Area Under the Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, and 24 hours post-dose
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Pre-dose and 0.5, 1, 2, 4, 6, 8,10, and 24 hours post-dose
|
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Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg'
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg'
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Maximum Observed Drug Concentration (Cmax)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
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Residual Area
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
calculated as 100*(1- AUC0-t / AUC0-inf)
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Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
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Time to Observed Cmax (Tmax)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels
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Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels
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Elimination Half-Life (T1/2 el)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
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Elimination Rate Constant (Kel)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
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Apparent Body Clearance (Cl/F)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
|
Apparent Volume of Distribution (Vd/F)
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
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Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) in Fed Versus Fasting State
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
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Area Under the Concentration-time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) in Fed Versus Fasting State
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
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Maximum Observed Drug Concentration (Cmax) in Fed Versus Fasting State
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg
|
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Time to Maximum Drug Concentration (Tmax) in Fed Versus Fasting State
Time Frame: Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels
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Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels
|
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Amount of Drug Excreted in Urine
Time Frame: Four hour intervals up to 12 hours, and then 12-24 hours post dose
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Four hour intervals up to 12 hours, and then 12-24 hours post dose
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Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t)
Time Frame: Four hour intervals up to 12 hours, and then 12-24 hours post dose
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Four hour intervals up to 12 hours, and then 12-24 hours post dose
|
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Maximum Rate of Urinary Excretion (Rmax)
Time Frame: Four hour intervals up to 12 hours, and then 12-24 hours post dose
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Four hour intervals up to 12 hours, and then 12-24 hours post dose
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Time of Rmax Urinary Excretion (TRmax)
Time Frame: Four hour intervals up to 12 hours, and then 12-24 hours post dose
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Four hour intervals up to 12 hours, and then 12-24 hours post dose
|
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Renal Clearance (Clr)
Time Frame: Four hour intervals up to 12 hours, and then 12-24 hours post dose
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Calculated by the following equation: Ae0-t/AUC0-24
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Four hour intervals up to 12 hours, and then 12-24 hours post dose
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Email: daniel.bouthillier@Kaneq.ca, Kaneq Bioscience
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KQ-791-01
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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