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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of TAK-831 when administered as multiple oral doses at escalating dose levels in healthy participants.
This study is a randomized, investigator and participant blinded, sponsor unblinded, placebo-controlled, study of the safety, tolerability and pharmacokinetics of TAK-831 in up to 48 healthy volunteers, with 8 subjects in each of the 6 cohorts.
In each cohort, participants will be randomized in a 3:1 ratio to receive TAK-831 or placebo. Two formulations, oral suspension and tablet will be tested in this study. Both blood and cerebrospinal fluid (CSF) samples will be collected from selected cohorts (CSF cohorts); for the rest of the cohorts, only blood samples will be collected (non-CSF cohorts).
This single-center trial will be conducted in the United States. The overall time to participate in this study is 58 days. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (Pooled) | Other | TAK-831 placebo-matching suspension, orally, once daily (QD) for up to Day 16. |
|
| TAK-831 100 mg | Experimental | TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16. |
|
| TAK-831 300 mg | Experimental | TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16. |
|
| TAK-831 600 mg | Experimental | TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16. |
|
| TAK-831 15 mg | Experimental | TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16. |
|
| TAK-831 800 mg | Experimental | TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-831 Tablet T2 | Drug | Tak-831 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug. | Baseline up to 30 days after the last dose (Up to 48 days) |
| Percentage of Participants Who Met the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Postdose | Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as: alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN), albumin<25 g/L, alkaline phosphatase >3.0 U/L*ULN, aspartate aminotransferase >3.0 U/L*ULN, bilirubin >3.42 umol/L creatinine >177umol/L, gamma glutamyl transferase (GGT) >3 U/L*ULN, glucose <2.8 mmol/L, >19.4 mmol/L, potassium<3 mmol/L, >6 mmol/L, sodium <130 mmol/L, >150 mmol/L, protein <0.8 g/L,* lower limit of normal (LLN), >1.2 g/L*ULN, erythrocytes <0.8 (10^12/L)*LLN, >1.2 (10^12/L)*ULN, hematocrit (%) <0.8*LLN, >1.2*ULN, hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN, leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN, platelets <75(10^9/L), >600(10^9/L). Only categories with values have been reported. | Baseline up to 30 days after the last dose (Up to 48 days) |
| Percentage of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose | Vital signs included temperature, pulse rate and blood pressure. Markedly abnormal values during treatment period were categorized as: Pulse Rate (beats/min) <50->120, Systolic Blood Pressure (SBP) (mmHg) <85->180, Diastolic Blood Pressure (DBP) (mmHg) <50->110 and Temperature (degree centigrades) <35.6- >37.7. | Baseline up to 30 days after the last dose (Up to 48 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-831 | 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Day 1 | |
| Cmax ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831 | 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Day 16 |
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Inclusion Criteria:
Exclusion Criteria:
Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in.
Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as >3 drinks per day) within 5 years before the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. (1 drink=12 ounce [oz]. beer=5 oz. wine=1.5 oz. liquor.)
Has a QT interval with Fridericia's correction method (QTcF) >450 milliseconds (ms) (male participants) or >470 ms (female participants) or PR outside the range of 120 to 220 ms, confirmed with 1 repeat testing, at the Screening Visit or Check-in. When triplicate electrocardiogram (ECG) assessments are collected, the mean of the 3 QTcF and PR values should be used to assess this criterion.
Has a positive test result for hepatitis B surface antigen (HBsAg), anti- human chorionic gonadotropin (HCV), or human immunodeficiency virus (HIV) antibody/antigen at Screening.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days before Check-in. Cotinine test is positive at Screening or Check-in.
Has poor peripheral venous access.
Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days before the first dose of study medication.
Has a Screening or Check-in abnormal (clinically significant) ECG. Entry of any participant with an abnormal (not clinically significant) ECG must be approved and documented by signature by the principal investigator or designee.
Has a supine blood pressure outside 90 to 140 millimeter of mercury (mm Hg) for systolic and 50 to 90 mm Hg for diastolic, confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in.
Has a resting heart rate outside 40 to 100 beats per minute confirmed on repeat testing within a maximum of 30 minutes, at the Screening Visit or Check-in (heart rate from the ECG does not apply).
Has a risk of suicide according to the Investigator's clinical judgment (example, per Columbia-Suicide Severity Rating Scale [C-SSRS]), or has scored "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior", if this behavior occurred in the past 2 years.
Additional Exclusion Criteria for Cohort(s) with cerebrospinal fluid (CSF) Collection:
Has had CSF collection performed within 30 days before Check-in.
Has a history of clinically significant back pain and/or injury.
Has local infection at the puncture site.
Has thrombocytopenia or other suspected bleeding tendencies noted before procedure.
Has developed signs and symptoms of spinal radiculopathy, including lower extremity pain and paresthesia.
Has any focal neurological deficit that might suggest an increase in intracranial pressure.
Has any abnormal findings on ophthalmological assessment/fundoscopy suggestive of raised intracranial pressure (that is, optic disc swelling/edema; (uncontrolled) hypertensive retinopathy).
Suffers regularly from moderate to severe headaches requiring analgesics.
Has lower spinal malformations (on physical examination or lumbar spine radiography), local spinal infection, or other abnormalities that would exclude lumbar puncture (LP).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group/PAREXEL | Glendale | California | 91206 | United States |
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Healthy volunteers were enrolled in a 1:3 ratio to receive placebo or TAK-831 in 6 cohorts.
Participants took part in the study at 1 investigative site in the United States from 21-Jul-2017 to 9-Sep-2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Pooled) | TAK-831 placebo-matching suspension, orally, once daily (QD) on Days 1 and 3 to 16. |
| FG001 | TAK-831 100 mg | TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| FG002 | TAK-831 300 mg | TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| FG003 | TAK-831 600 mg | TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| FG004 | TAK-831 15 mg | TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16. |
| FG005 | TAK-831 800 mg | TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
| FG006 | TAK-831 1200 mg | TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Pooled) | TAK-831 placebo-matching suspension, orally, QD on Days 1 and 3 to 16. |
| BG001 | TAK-831 100 mg | TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| 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 | Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug. | Safety set included all randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline up to 30 days after the last dose (Up to 48 days) |
|
Baseline up to 30 days after the last dose (Up to 48 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Safety set included all randomized participants who received at least 1 dose of study drug.
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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 | Placebo (Pooled) | TAK-831 placebo-matching suspension, orally, QD on Days 1 and 3 to 16. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neurocrine Medical Information | Neurocrine Biosciences | 877-641-3461 | +1 | medinfo@neurocrine.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2018 | Sep 5, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2018 | Sep 5, 2019 | SAP_001.pdf |
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|
| TAK-831 1200 mg | Experimental | TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
|
| Placebo | Drug | TAK-831 placebo-matching suspension. |
|
| TAK-831 Suspension | Drug | TAK-831 Suspension. |
|
| Percentage of Participants Who Met the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose | A 12-lead ECG was performed. Markedly abnormal values during treatment period were categorized as: ECG Mean Heart Rate (beats/min) <50->120, PR Interval, Aggregate (msec) <=80->=200, QRS Duration, Aggregate (msec) <=80->=180, QT Interval, Aggregate (msec) <=300->=460, QTcF Interval, Aggregate (msec) <=300->=500 OR >=30 change from baseline and >=450 milliseconds. | Baseline up to 30 days after the last dose (Up to 48 days) |
| Tmax: Time of First Occurrence of Cmax for TAK-831 | 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Days 1 and 16 |
| AUC0-24: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-831 | 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Days 1 and 16 |
| Withdrawal by Subject |
|
| BG002 | TAK-831 300 mg | TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| BG003 | TAK-831 600 mg | TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| BG004 | TAK-831 15 mg | TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16. |
| BG005 | TAK-831 800 mg | TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
| BG006 | TAK-831 1200 mg | TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index (BMI) | BMI=Weight/Height^2. | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | TAK-831 100 mg | TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| OG002 | TAK-831 300 mg | TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| OG003 | TAK-831 600 mg | TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16. |
| OG004 | TAK-831 15 mg | TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16. |
| OG005 | TAK-831 800 mg | TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
| OG006 | TAK-831 1200 mg | TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. |
|
|
| Primary | Percentage of Participants Who Met the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Postdose | Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as: alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN), albumin<25 g/L, alkaline phosphatase >3.0 U/L*ULN, aspartate aminotransferase >3.0 U/L*ULN, bilirubin >3.42 umol/L creatinine >177umol/L, gamma glutamyl transferase (GGT) >3 U/L*ULN, glucose <2.8 mmol/L, >19.4 mmol/L, potassium<3 mmol/L, >6 mmol/L, sodium <130 mmol/L, >150 mmol/L, protein <0.8 g/L,* lower limit of normal (LLN), >1.2 g/L*ULN, erythrocytes <0.8 (10^12/L)*LLN, >1.2 (10^12/L)*ULN, hematocrit (%) <0.8*LLN, >1.2*ULN, hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN, leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN, platelets <75(10^9/L), >600(10^9/L). Only categories with values have been reported. | Safety set included all randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline up to 30 days after the last dose (Up to 48 days) |
|
|
|
| Primary | Percentage of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose | Vital signs included temperature, pulse rate and blood pressure. Markedly abnormal values during treatment period were categorized as: Pulse Rate (beats/min) <50->120, Systolic Blood Pressure (SBP) (mmHg) <85->180, Diastolic Blood Pressure (DBP) (mmHg) <50->110 and Temperature (degree centigrades) <35.6- >37.7. | Safety set included all randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline up to 30 days after the last dose (Up to 48 days) |
|
|
|
| Primary | Percentage of Participants Who Met the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose | A 12-lead ECG was performed. Markedly abnormal values during treatment period were categorized as: ECG Mean Heart Rate (beats/min) <50->120, PR Interval, Aggregate (msec) <=80->=200, QRS Duration, Aggregate (msec) <=80->=180, QT Interval, Aggregate (msec) <=300->=460, QTcF Interval, Aggregate (msec) <=300->=500 OR >=30 change from baseline and >=450 milliseconds. | Safety set included all randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline up to 30 days after the last dose (Up to 48 days) |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-831 | The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration. | Posted | Mean | Standard Deviation | ng/mL | 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Day 1 |
|
|
|
| Secondary | Cmax ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831 | The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration with data available for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Day 16 |
|
|
|
| Secondary | Tmax: Time of First Occurrence of Cmax for TAK-831 | The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration. Number analyzed is the number of participants with data available for analysis for the given timepoint. | Posted | Median | Full Range | hours (hr) | 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Days 1 and 16 |
|
|
|
| Secondary | AUC0-24: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-831 | The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration with data available for this outcome measure. | Posted | Mean | Standard Deviation | hr*ng/mL | 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Days 1 and 16 |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 9 |
| 13 |
| EG001 | TAK-831 100 mg | TAK-831 100 mg, tablets, orally, QD on Days 1 and 3 to 16. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | TAK-831 300 mg | TAK-831 300 mg, tablets, orally, QD on Days 1 and 3 to 16. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | TAK-831 600 mg | TAK-831 600 mg, tablets, orally, QD on Days 1 and 3 to 16. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | TAK-831 15 mg | TAK-831 15 mg, suspension, orally, multiple doses (MD) daily, on Days 1 and 3 to 16. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG005 | TAK-831 800 mg | TAK-831 800 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG006 | TAK-831 1200 mg | TAK-831 1200 mg, suspension, orally, QD on Day 1, MD on Days 3 to 16. | 0 | 7 | 0 | 7 | 3 | 7 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Medical device site reaction | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Micturition disorder | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Orthostatic intolerance | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
Generally, the PI may publish results of the study following the publication of results by the Sponsor.
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| Day 16 |
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| Day 16 |
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