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This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD8108 or placebo will be administered orally as a solution, and a 4- to 10-day follow-up period after discharge.
In Part 1 of the study (single ascending dose portion), approximately 32 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts (AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD8108 or placebo on Day 1. In Part 2 of the study (multiple ascending dose portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each subject will receive twelve doses of either AZD8108 or placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD8108 | Experimental | Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 6 subjects will receive AZD8108 |
|
| Placebo to match AZD8108 | Placebo Comparator | Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 2 subjects will receive matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8108 | Drug | Drug: AZD8108 Single or Multiple doses administered orally as a solution. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal | Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal | Day -1 to 7 days after last dose |
| Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108 | Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108 | Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose |
| Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108 | Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 6 | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose |
| Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108 | Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 12 | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose |
| Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108 | Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 & 7, Cohort 6 dod not reach Day 12 | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose |
| Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108 | Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108 | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose |
| Measure | Description | Time Frame |
|---|---|---|
| EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction | EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest | 8 hours after dose |
Inclusion Criteria: Inclusion Criteria: 1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures. 2. Men and postmenopausal or surgically sterile women age 18-55 years inclusive. 3. Subjects must have a body mass index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive. 4.Subjects must be fluent in English.
-
Exclusion Criteria:1. A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality. 2. A clinically significant abnormality on physical examination, neurological examination, EEG, ECG, vital signs or laboratory evaluations at screen or between screen and dose administration. 3. A history of seizure. 4.A history of head trauma, including closed head injury with loss of consciousness. 5.Any history of suicide attempt or suicidal behavior, or, in the opinion of the investigator, clinically significant risk of suicide or violent behavior. 6. Urine drug screen positive for a drug of abuse 7. A family history of schizophrenia, schizoaffective disorder, or psychosis in first degree relatives.
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| Name | Affiliation | Role |
|---|---|---|
| Mina Pastagia, MD, MS | Clinilabs, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinilabs, Inc. | New York | New York | 10019 | United States |
Protocol allowed for 258 subjects to be screened, only 155 subjects were screened before all cohorts for the study were filled and recruitment ended.
Healthy Adult volunteer study, Part 1: SAD: single ascending dose cohorts, followed by Part 2: MAD: multiple ascending dose cohorts. Plan was for each cohort to have 8 subjects, 2 placebo dosed and 6 AZD8108 dosed.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD8108 20 mg SAD | AZD8108 20 mg SAD, Cohort 1 |
| FG001 | AZD8108 60 mg SAD | AZD8106 60 mg SAD, Cohort 2 |
| FG002 | AZD8108 95 mg SAD | AZD8108 95 mg SAD, Cohort 3 |
| FG003 | Placebo SAD | Placebo SAD, pooled across Cohorts 1 - 3 |
| FG004 | AZD8108 50 mg | AZD8108 50 mg MAD, Cohort 5 |
| FG005 | AZD8108 90 mg MAD (6) | AZD8108 90 mg MAD, Cohort 6 |
| FG006 | AZD8108 90 mg MAD (7) | AZD8108 90 mg MAD, Cohort 7 |
| FG007 | Placebo MAD | Placebo MAD, pooled across Cohorts 5 & 7 |
| FG008 | Screen | Screen - no treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
|
| ||||||||||||||||||
| Randomised Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD8108 20 mg - SAD | AZD8108 20 mg SAD, Cohort 1 |
| BG001 | AZD8108 60 mg - SAD | AZD8108 60 mg SAD, Cohort 2 |
| 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 | Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal | Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal | Safety population | Posted | Number | Participants | Day -1 to 7 days after last dose |
|
SAD cohorts 2 weeks, MAD cohorts up to 1 month
From Day -1 (entry into unit) until 14 days after last dose (15 days for SAD cohorts and up to 29 days for MAD cohorts) note Mad Cohort 6, stopped due to randomisation error in pharmacy had 15 days of follow up for adverse events.
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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 | AZD8108 20 mg SAD | AZD8108 20 mg SAD, Cohort 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
Conversion of AZD8108 to active moiety AZD6567 was rapid, concentrations of AZD8108 were almost all below the level of quantification, no PK parameters were calculable for AZD8108 concentrations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Posner MD | AstraZeneca LP | ClinicalTrialTransparency@astrazeneca.com |
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| Placebo |
| Drug |
Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution |
|
Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108 |
| Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose |
| Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108 | Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 6 | Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose |
| Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108 | Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 12 | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose |
| Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108 |
Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3) |
| Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose |
| Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108 | Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12 | Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose |
| Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108 | Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12 | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose |
| Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD | Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 & 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)] | Day 12 compared to Day 1 |
| EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction | EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest | 8 hours after dose |
| EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction | EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest | 8 hours after dose |
| Study fully enrolled |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 |
| AZD8108 95 mg - SAD |
AZD8108 95 mg SAD, Cohort 3 |
| BG003 | Placebo SAD | Placebo SAD, pooled across Cohorts 1 - 3 |
| BG004 | AZD8108 50 mg MAD | AZD8108 50 mg MAD, Cohort 5 |
| BG005 | AZD8108 90 mg MAD (6) | AZD8108 90 mg MAD, Cohort 6 |
| BG006 | AZD8108 90 mg MAD (7) | AZD8108 90 mg MAD, Cohort 7 |
| BG007 | Placebo MAD | Placebo MAD, pooled across Cohorts 5 & 7 |
| BG008 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
AZD8108 95 mg SAD, Cohort 3
| OG003 | Placebo SAD | Placebo SAD, pooled across Cohorts 1 - 3 |
| OG004 | AZD8108 50 mg MAD | AZD8108 50 mg MAD, Cohort 5 |
| OG005 | AZD8108 90 mg MAD (6) | AZD8108 90 mg MAD, Cohort 6 |
| OG006 | AZD8108 90 mg MAD (7) | AZD8108 90 mg MAD, Cohort 7 |
| OG007 | Placebo MAD | Placebo MAD, pooled across Cohorts 5 & 7 |
|
|
| Primary | Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108 | Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108 | Pharmacokinetic Population (those dosed with AZD8108) | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose |
|
|
|
| Primary | Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108 | Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 6 | Pharmacokinetic Population (those dosed with AZD8108) | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose |
|
|
|
| Primary | Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108 | Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 12 | Pharmacokinetic Population (those dosed with AZD8108) | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose |
|
|
|
| Primary | Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108 | Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 & 7, Cohort 6 dod not reach Day 12 | Pharmacokinetic Population (those dosed with AZD8108) | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose |
|
|
|
| Primary | Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108 | Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108 | Pharmacokinetic Population (those dosed with AZD8108) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose |
|
|
|
| Primary | Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108 | Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 6 | Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose |
|
|
|
| Primary | Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108 | Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 12 | Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose |
|
|
|
| Secondary | Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108 | Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108 | Pharmacokinetic population (subjects dosed with AZD8108) | Posted | Median | Full Range | hours | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose |
|
|
|
| Secondary | Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108 | Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3) | Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed | Posted | Geometric Mean | Geometric Coefficient of Variation | Percent | Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose | Participants with urine volume data | Participants with urine volume data |
|
|
|
| Secondary | Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108 | Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12 | Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed | Posted | Geometric Mean | Geometric Coefficient of Variation | Percent | Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose |
|
|
|
| Secondary | Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108 | Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12 | Pharmacokinetic population (subjects dosed with AZD8108) | Posted | Median | Full Range | hours | Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose |
|
|
|
| Secondary | Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD | Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 & 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)] | Pharmacokinetic population, MAD Cohorts 5 & 7 | Posted | Mean | Standard Deviation | ratio | Day 12 compared to Day 1 |
|
|
|
| Other Pre-specified | EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction | EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest | Safety population | Posted | Mean | Standard Deviation | uV2 | 8 hours after dose |
|
|
|
| Other Pre-specified | EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction | EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest | Safety population | Posted | Mean | Standard Deviation | uV2 | 8 hours after dose |
|
|
|
| Other Pre-specified | EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction | EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest | Safety population | Posted | Mean | Standard Deviation | uV2 | 8 hours after dose |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | AZD8108 60 mg SAD | AZD8106 60 mg SAD, Cohort 2 | 0 | 6 | 4 | 6 |
| EG002 | AZD8108 95 mg SAD | AZD8108 95 mg SAD, Cohort 3 | 0 | 6 | 4 | 6 |
| EG003 | Placebo SAD | Placebo SAD, pooled across Cohorts 1 - 3 | 0 | 6 | 3 | 6 |
| EG004 | AZD8108 50 mg MAD | AZD8108 50 mg MAD, Cohort 5 | 0 | 6 | 3 | 6 |
| EG005 | AZD8108 90 mg MAD (6) | AZD8108 90 mg MAD, Cohort 6 | 0 | 8 | 1 | 8 |
| EG006 | AZD8108 90 mg MAD (7) | AZD8108 90 mg MAD, Cohort 7 | 0 | 6 | 4 | 6 |
| EG007 | Placebo MAD | Placebo MAD, pooled across Cohorts 5 & 7 | 0 | 4 | 3 | 4 |
| Palpitations | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Muscle Twitching | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dysguesia | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Nystagmus | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Halucination, visual | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
Not provided
| Participants with urine volume data |
|
| 1 hour after dose |
|
| 1.5 hours after dose |
|
| 2 hours after dose |
|
| 3 hours after dose |
|
| 5 hours after dose |
|
| 8 hours after dose |
|
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| 1 hour after dose |
|
| 1.5 hours after dose |
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| 2 hours after dose |
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| 3 hours after dose |
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| 5 hours after dose |
|
| 8 hours after dose |
|
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| 1 hours post dose |
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| 1.5 hours post dose |
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| 2 hours post dose |
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| 3 hours post dose |
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| 5 hours post dose |
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| 8 hours post dose |
|