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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002478-39 | EudraCT Number |
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Preclinical finding
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The purpose of this study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose: MT-6345 & Placebo | Experimental |
| |
| Multiple Ascending Dose: MT-6345 & Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-6345 | Drug | MT-6345 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Mild, Moderate and Severe Adverse Events | The criteria of Mild, Moderate and Severe are as follows: Mild: The event is transient and easily tolerated by the subject. Moderate: The event causes discomfort and interferes with the subject's general condition. Severe: The event causes considerable interference with the subject's general condition and may be incapacitating. | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of MT-6345 | Cmax was measured for MT-6345 for the PK analysis set (PKPOP) subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
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Inclusion Criteria:
Additional screening criteria check may apply for qualification:
Exclusion Criteria:
Additional screening criteria check may apply for qualification:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Medical Science, | Tanabe Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational center | City Name | United Kingdom |
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6 subjects of Part 1 were selected for Part 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 and Part 2 Placebo | Single dose |
| FG001 | Part 1: MT-6345 1 mg | Single dose |
| FG002 | Part 1: MT-6345 5 mg | Single dose |
| FG003 | Part 1 and Part 2: MT-6345 20 mg | Single dose |
| FG004 | Part 1: MT-6345 60 mg | Single dose |
| FG005 | Part 1: MT-6345 120 mg | Single dose |
| FG006 | Part 1: MT-6345 240 mg | Single dose |
| FG007 | Part 3: Placebo | Multiple dose |
| FG008 | Part 3: MT-6345 60 mg | Multiple dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 |
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| Part 2 |
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| Part 3 |
|
The analysis population is the subjects of Part 1 and Part 3 since the subjects of part 2 were selected from part 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 Placebo | Single dose |
| BG001 | Part 1: MT-6345 1 mg | Single dose |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 Mild, Moderate and Severe Adverse Events | The criteria of Mild, Moderate and Severe are as follows: Mild: The event is transient and easily tolerated by the subject. Moderate: The event causes discomfort and interferes with the subject's general condition. Severe: The event causes considerable interference with the subject's general condition and may be incapacitating. | Posted | Number | participants | Up to 6 weeks |
|
From the time written informed consent was obtained from a subject until the end of the Follow-up Period or the withdrawal from the study were recorded, up to 6 weeks.
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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 | Part 1 Placebo | Single dose | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical device site reaction | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma America, Inc. | Please e-mail | information.US@mb.tanabe-pharma.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 | Dec 12, 2018 | Jun 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2020 | Jun 2, 2021 | SAP_001.pdf |
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| MT-6345 Placebo | Drug | MT-6345 Placebo |
|
| Time to Maximum Plasma Concentration (Tmax) of MT-6345 | Tmax was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
| Plasma Terminal Elimination Half Life (t½) of MT-6345 | t1/2 was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
| Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC0-24h) of MT-6345 | AUC(0-24h) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
| Area Under the Plasma Concentration Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of MT-6345 | AUC(0-last) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of MT-6345 | AUC(0-∞) was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hour. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
| Terminal Elimination Rate Constant (Kel) of MT-6345 | Kel was estimated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
| Mean Residence Time (MRT) of MT-6345 | MRT was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
| Apparent Oral Clearance (CL/F) of MT-6345 | CL/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
| Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC0-t) of MT-6345. | up to 2 weeks after dosing |
| Apparent Volume of Distribution at Steady State (Vss/F) of MT-6345 | Vss/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3. | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
| Linearity Factor (LF) of MT-6345 | up to 2 weeks after dosing |
| Accumulation Ratio (RA) of MT-6345 | up to 2 weeks after dosing |
| Urinary Excreted Amount of Test Compound (Ae) of MT-6345 | Ae was measured for MT-6345 for the PKPOP subjects in Part 3. | Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours) |
| Urinary Excreted Amount of Test Compound Expressed as a Percentage of the Dose Administered (Ae%) of MT-6345 | Ae% was measured for MT-6345 for the PKPOP subjects in Part 3. | Day 1 (pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 16 hours) and Day 2 to Day 10 (pre-dose on each day) |
| Renal Clearance (CLR) of MT-6345 | CLR was measured for MT-6345 for the PKPOP subjects in Part 3. For Day 10, CLR was not calculated because AUC(0-24h) on the last day of dosing was not calculated. | Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours) |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| Part 1: MT-6345 5 mg |
Single dose |
| BG003 | Part 1: MT-6345 20 mg | Single dose |
| BG004 | Part 1: MT-6345 60 mg | Single dose |
| BG005 | Part 1: MT-6345 120 mg | Single dose |
| BG006 | Part 1: MT-6345 240 mg | Single dose |
| BG007 | Part 3 Placebo | Multiple dose |
| BG008 | Part 3: MT-6345 60 mg | Multiple dose |
| BG009 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Single dose |
| OG003 | Part 1: MT-6345 20 mg | Single dose |
| OG004 | Part 1: MT-6345 60 mg | Single dose |
| OG005 | Part 1: MT-6345 120 mg | Single dose |
| OG006 | Part 1: MT-6345 240 mg | Single dose |
| OG007 | Part 2: Placebo | Single dose |
| OG008 | Part 2: MT-6345 20 mg | Single dose |
| OG009 | Part 3: Placebo | Multiple dose |
| OG010 | Part 3: MT-6345 60 mg | Multiple dose |
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of MT-6345 | Cmax was measured for MT-6345 for the PK analysis set (PKPOP) subjects in Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Posted | Mean | Standard Deviation | ng/mL | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) of MT-6345 | Tmax was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Posted | Median | Full Range | hour | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Plasma Terminal Elimination Half Life (t½) of MT-6345 | t1/2 was measured for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Posted | Mean | Standard Deviation | hour | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC0-24h) of MT-6345 | AUC(0-24h) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Posted | Mean | Standard Deviation | ng.h/mL | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Area Under the Plasma Concentration Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of MT-6345 | AUC(0-last) was computed for MT-6345 for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Posted | Mean | Standard Deviation | ng.h/mL | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of MT-6345 | AUC(0-∞) was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects in Part 1, Part 2, and on Day 1 in Part 3. | Posted | Mean | Standard Deviation | ng.h/mL | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hour. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Terminal Elimination Rate Constant (Kel) of MT-6345 | Kel was estimated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | Posted | Mean | Standard Deviation | /h | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Mean Residence Time (MRT) of MT-6345 | MRT was calculated for the PKPOP subjects in Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects in Part 1, Part 2 and on Day 1 in Part 3. | Posted | Mean | Standard Deviation | hour | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Apparent Oral Clearance (CL/F) of MT-6345 | CL/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects of Part 1, Part 2, and on Day 1 in Part 3. | Posted | Mean | Standard Deviation | litre per hour | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUC0-t) of MT-6345. | AUC0-t was not collected, and could not be assessed due to early study termination. | Posted | up to 2 weeks after dosing |
|
|
| Secondary | Apparent Volume of Distribution at Steady State (Vss/F) of MT-6345 | Vss/F was measured for MT-6345 in the PKPOP subjects of Part 1 and Part 2, and on Day 1 in Part 3. | PKPOP subjects of Part 1, Part 2, and on Day 1 in Part 3. | Posted | Mean | Standard Deviation | litre(s) | Part 1 and Part 2: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72 (Day 4), 120 (Day 6), 192 (Day 9), and 336 (Day 15 Follow-up Visit) hours. Part 3: Pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours. |
|
|
|
| Secondary | Linearity Factor (LF) of MT-6345 | LF was not collected, and could not be assessed due to early study termination. | Posted | up to 2 weeks after dosing |
|
|
| Secondary | Accumulation Ratio (RA) of MT-6345 | RA was not collected, and could not be assessed due to early study termination. | Posted | up to 2 weeks after dosing |
|
|
| Secondary | Urinary Excreted Amount of Test Compound (Ae) of MT-6345 | Ae was measured for MT-6345 for the PKPOP subjects in Part 3. | PKPOP subjects in Part 3. | Posted | Mean | Standard Deviation | milligram(s) | Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours) |
|
|
|
| Secondary | Urinary Excreted Amount of Test Compound Expressed as a Percentage of the Dose Administered (Ae%) of MT-6345 | Ae% was measured for MT-6345 for the PKPOP subjects in Part 3. | PKPOP subjects in Part 3. | Posted | Mean | Standard Deviation | percentage of dose | Day 1 (pre-dose and post-dose at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 16 hours) and Day 2 to Day 10 (pre-dose on each day) |
|
|
|
| Secondary | Renal Clearance (CLR) of MT-6345 | CLR was measured for MT-6345 for the PKPOP subjects in Part 3. For Day 10, CLR was not calculated because AUC(0-24h) on the last day of dosing was not calculated. | PKPOP subjects in Part 3. | Posted | Mean | Standard Deviation | L/h | Day 1 (0 hours to 24 hours) and Day 10 (0 hours to 24 hours) |
|
|
|
| 11 |
| 0 |
| 11 |
| 4 |
| 11 |
| EG001 | Part 1: MT-6345 1 mg | Single dose | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Part 1: MT-6345 5 mg | Single dose | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | Part 1: MT-6345 20 mg | Single dose | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Part 1: MT-6345 60 mg | Single dose | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | Part 1: MT-6345 120 mg | Single dose | 0 | 4 | 0 | 4 | 1 | 4 |
| EG006 | Part 1: MT-6345 240 mg | Single dose | 0 | 5 | 0 | 5 | 2 | 5 |
| EG007 | Part 2: Placebo | Single dose | 0 | 1 | 0 | 1 | 0 | 1 |
| EG008 | Part 2: MT-6345 20 mg | Single dose | 0 | 5 | 0 | 5 | 2 | 5 |
| EG009 | Part 3: Placebo | Multiple dose | 0 | 2 | 0 | 2 | 0 | 2 |
| EG010 | Part 3: MT-6345 60 mg | Multiple dose | 0 | 6 | 0 | 6 | 2 | 6 |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Fungal skin infections | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
Not provided