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The purpose of this study is to assess the safety, tolerability, and the effect of food on KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different dose levels) and 1 placebo dose over the course of the study. Up to 6 escalating dose levels may be studied, in two distinct groups or cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KQ-791 | Experimental | Escalating doses of KQ-791, starting at 15 milligrams |
|
| KQ-791 (after meal) | Experimental | Single dose of KQ-791 in capsule form, after a meal |
|
| Placebo | Placebo Comparator | Single dose of placebo matching KQ-791 dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KQ-791 | Drug | Capsules administered orally while fasting, in up to 3 periods |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug | Baseline to study completion (up to 11 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) | 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 | |
| Area Under the Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) |
Not provided
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:
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:
Some degree of insulin resistance, as shown by:
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:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Email: daniel.bouthillier@Kaneq.ca | Kaneq Bioscience | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inventiv | Montreal | Quebec | H3X 2Hp | Canada | ||
| inVentiv |
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Sequence 60 mg/600 mg/Placebo subject discontinued after completion of 600 mg. Sequence Placebo/600 mg/1800 mg subject discontinued after completion of placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence: 15 mg/Placebo/1200 mg/Placebo (Fed) | |
| FG001 | Sequence: 15 mg KQ791/195 mg/Placebo/195 mg (Fed) | |
| FG002 | Sequence: Placebo/195 mg/1200 mg/195 mg (Fed) | |
| FG003 | Sequence: 60 mg/Placebo/1800 mg | |
| FG004 | Sequence: 60 mg/600 mg/Placebo | |
| FG005 | Sequence: Placebo/600 mg/1800 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug | Posted | Number | participants | Baseline to study completion (up to 11 weeks) |
|
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Collected at each visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 15 mg KQ-791 (Fasting) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gosse Bruinsma | Kaneq Bioscience Limited | 1-613-800-0955 | gosse.bruinsma@kaneqbioscience.ca |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019518 | Postprandial Period |
| ID | Term |
|---|---|
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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| KQ-791 (after meal) |
| Drug |
Single dose of KQ-791 in capsules, after a meal, in 1 period |
|
| Placebo | Drug | Capsules, administered orally, in 1 period |
|
| Pre-dose and 0.5, 1, 2, 4, 6, 8,10, and 24 hours post-dose |
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) | 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' |
| Maximum Observed Drug Concentration (Cmax) | 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 |
| Residual Area | calculated as 100*(1- AUC0-t / AUC0-inf) | 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 |
| Time to Observed Cmax (Tmax) | 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 |
| Elimination Half-Life (T1/2 el) | 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 |
| Elimination Rate Constant (Kel) | 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 Body Clearance (Cl/F) | 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) | 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 |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) in Fed Versus Fasting State | 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 |
| Area Under the Concentration-time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) in Fed Versus Fasting State | 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 |
| Maximum Observed Drug Concentration (Cmax) in Fed Versus Fasting State | 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 |
| Time to Maximum Drug Concentration (Tmax) in Fed Versus Fasting State | 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 |
| Amount of Drug Excreted in Urine | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
| Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
| Maximum Rate of Urinary Excretion (Rmax) | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
| Time of Rmax Urinary Excretion (TRmax) | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
| Renal Clearance (Clr) | Calculated by the following equation: Ae0-t/AUC0-24 | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
| Québec |
| G1P 0A2 |
| Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 600 mg KQ-791 (Fasting) |
| OG005 | 1200 mg KQ-791 (Fasting) |
| OG006 | 1800 mg Kq-791 (Fasting) |
| OG007 | Placebo (Fed) |
| OG008 | Placebo (Fasting) |
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUC0-t. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUC0-24. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose and 0.5, 1, 2, 4, 6, 8,10, and 24 hours post-dose |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUC0-inf. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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' |
|
|
|
| Secondary | Maximum Observed Drug Concentration (Cmax) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
|
|
| Secondary | Residual Area | calculated as 100*(1- AUC0-t / AUC0-inf) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Residual Area. | Posted | Geometric Mean | Geometric Coefficient of Variation | Percentage residual area under the AUC | 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 |
|
|
|
| Secondary | Time to Observed Cmax (Tmax) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Tmax. | Posted | Median | Full Range | Hours | 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 |
|
|
|
| Secondary | Elimination Half-Life (T1/2 el) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute T1/2 el. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | 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 |
|
|
|
| Secondary | Elimination Rate Constant (Kel) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Kel. | Posted | Geometric Mean | Geometric Coefficient of Variation | Per hour | 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 |
|
|
|
| Secondary | Apparent Body Clearance (Cl/F) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute CI/F. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour (L/h) | 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 |
|
|
|
| Secondary | Apparent Volume of Distribution (Vd/F) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Vd/F. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | 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 |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) in Fed Versus Fasting State | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUC0-inf in Fed versus Fasting State. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) in Fed Versus Fasting State | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
|
|
|
| Secondary | Maximum Observed Drug Concentration (Cmax) in Fed Versus Fasting State | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
|
|
| Secondary | Time to Maximum Drug Concentration (Tmax) in Fed Versus Fasting State | Posted | Median | Full Range | Hours | 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 |
|
|
|
| Secondary | Amount of Drug Excreted in Urine | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute the Amount of Drug Excreted in Urine. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
|
|
|
| Secondary | Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Ae0-t. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
|
|
|
| Secondary | Maximum Rate of Urinary Excretion (Rmax) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Rmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/hour | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
|
|
|
| Secondary | Time of Rmax Urinary Excretion (TRmax) | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute TRmax. | Posted | Median | Full Range | Hours | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
|
|
|
| Secondary | Renal Clearance (Clr) | Calculated by the following equation: Ae0-t/AUC0-24 | All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Clr. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | Four hour intervals up to 12 hours, and then 12-24 hours post dose |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | 60 mg KQ-791 (Fasting) | 0 | 6 | 2 | 6 |
| EG002 | 195 mg KQ-791 (Fasting) | 0 | 6 | 3 | 6 |
| EG003 | 195 mg KQ-791 (Fed) | 0 | 6 | 2 | 6 |
| EG004 | 600 mg KQ-791 (Fasting) | 0 | 6 | 2 | 6 |
| EG005 | 1200 mg KQ-791 (Fasting) | 0 | 6 | 2 | 6 |
| EG006 | 1800 mg Kq-791 (Fasting) | 0 | 6 | 4 | 6 |
| EG007 | Placebo (Fasting) | 0 | 17 | 8 | 17 |
| EG008 | Placebo (Fed) | 0 | 3 | 1 | 3 |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Faeces discolored | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Abnormal faeces | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Gastresophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Blood tryglycerides increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Blood pressure increased | Nervous system disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| High density lipoprotein decreased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Heart Rate Increased | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Protein urine | Investigations | MedDRA 18.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| Oral herpes | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
|
| Lacrimation increases | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
|
Not provided