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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1170-1571 | Other Identifier | WHO | |
| JapicCTI-152897 | Registry Identifier | JapicCTI |
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The purpose of this study is to characterize the safety and tolerability profile of TAK-792 when administered as a single oral dose in healthy Japanese and Caucasian male participants.
This study will be double-blind and placebo-controlled to avoid subjective bias in the assessment of safety and tolerability of TAK-792. Sentinel dosing will be used in the first cohort (cohort 1) to ensure adequate safety and tolerability evaluation prior to administering TAK-792 to the remainder of participants within the cohort. The dose escalation to the next cohort for Cohorts 2 to 6 will occur after full review of safety and tolerability of the current cohort, and available pharmacokinetic data up to 24 hours in the preceding cohorts. The planned dose levels are 30, 100, 250, 500, 750 and 1250 mg, to be administered in the morning after a fast of at least 10 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1-active | Experimental | Single oral administration of TAK-792 30 milligram (mg) in Japanese participants |
|
| Cohort 1-placebo | Placebo Comparator | Single oral administration of TAK-792 30 mg placebo in Japanese participants |
|
| Cohort 2-active | Experimental | Single oral administration of TAK-792 100 mg in Japanese participants |
|
| Cohort 2-placebo | Placebo Comparator | Single oral administration of TAK-792 100 mg placebo in Japanese participants |
|
| Cohort 3-active | Experimental | Single oral administration of TAK-792 250 mg in Japanese participants |
|
| Cohort 3-placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-792 30 mg | Drug | TAK-792 30 mg was administered in the morning after a fast. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Baseline up to Day 8 | |
| Number of Participants With TEAE Related to Vital Signs | Vital signs included body temperature (infra-axillary measurement), supine blood pressure (systolic and diastolic) after the participant has rested for at least 5 minutes, respiratory rate, and pulse (beats per minute [bpm]). | Baseline up to Day 5 |
| Number of Participants With TEAE Related to Body Weight | Baseline up to Day 5 | |
| Number of Participants With TEAE Related to Electrocardiograms (ECG) | Baseline up to Day 5 | |
| Number of Participants With TEAEs Related to Laboratory Tests | Reported TEAE Related to Laboratory Tests are following; Occult blood positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood glucose increased, Blood triglycerides increased, Blood urine present, Protein urine present, and White blood cell count increased. | Baseline up to Day 5 |
| Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | The gastrointestinal (GI) symptoms (abdominal pain, heartburn, acid regurgitation, hunger pains, nausea, borborygmus, abdominal distension, eructation, increased flatus, constipation, diarrhoea, loose stools, hard stools, urgent need for defecation, and feeling of incomplete evacuation) using GSRS questionnaires at each assessment point. The GSRS a 15-item self-administered questionnaire that assesses the impact of GI symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms. TEAEs related to GSRS were reported as follows: Diarrhoea, Constipation, Faeces hard, and Faeces soft. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose | |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II |
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Inclusion Criteria:
Exclusion Criteria:.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kagoshima | Japan |
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Healthy Japanese participants received TAK-792 or placebo in Cohort 1a (30 milligram [mg]), Cohort 2a (100 mg), Cohort 3a (250 mg), Cohort 4a (500 mg), Cohort 5a (750 mg), and Cohort 6a (1250 mg). Healthy Caucasian participants received TAK-792 or placebo in Cohort 4b (500 mg), Cohort 5b (750 mg) and Cohort 6b (1250 mg).
Participants took part in the study at 1 investigative site in Japan from 27 May 2015 to 28 January 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1a-6a: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| FG001 | Cohort 1a: TAK-792 30 mg | TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| FG002 | Cohort 2a: TAK-792 100 mg | TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| FG003 | Cohort 3a: TAK-792 250 mg | TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| FG004 | Cohort 4a: TAK-792 500 mg | TAK-792 500 mg, tablets, orally, once in fasted state (4a-1) on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fed state (4a-2) on Day 1 of another 5-day treatment period. |
| FG005 | Cohort 5a: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state (5a-1), once on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fasted state (5a-2) on Day 1 of another 5-day treatment period. |
| FG006 | Cohort 6a: TAK-792 1250 mg | TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| FG007 | Cohort 4b-6b: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| FG008 | Cohort 4b: TAK-792 500 mg | TAK-792 500 mg, tablets, orally, once in fasted state (4b-1) on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fed state (4b-2) on Day 1 of another 5-day treatment period. |
| FG009 | Cohort 5b: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state (5b-1), once on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fasted state (5b-2) on Day 1 of another 5-day treatment period. |
| FG010 | Cohort 6b: TAK-792 1250 mg | TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Pharmacokinetic (PK) analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1a-6a: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| BG001 | Cohort 1a: TAK-792 30 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Baseline up to Day 8 |
|
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.
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.
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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 | Cohort 1a-6a: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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Single oral administration of TAK-792 250 mg placebo in Japanese participants
|
| Cohort 4-active | Experimental | Single oral administration of TAK-792 500 mg in Japanese and Caucasian participants |
|
| Cohort 4-placebo | Placebo Comparator | Single oral administration of TAK-792 500 mg placebo in Japanese and Caucasian participants |
|
| Cohort 5-active | Experimental | Single oral administration of TAK-792 750 mg in Japanese and Caucasian participants |
|
| Cohort 5-placebo | Placebo Comparator | Single oral administration of TAK-792 750 mg placebo in Japanese and Caucasian participants |
|
| Cohort 6-active | Experimental | Single oral administration of TAK-792 1250 mg in Japanese and Caucasian participants |
|
| Cohort 6-placebo | Placebo Comparator | Single oral administration of TAK-792 1250 mg placebo in Japanese and Caucasian participants |
|
| TAK-792 30 mg placebo |
| Drug |
TAK-792 30 mg placebo was administered in the morning after a fast. |
|
| TAK-792 100 mg | Drug | TAK-792 100 mg was administered in the morning after a fast. |
|
| TAK-792 100 mg placebo | Drug | TAK-792 100 mg placebo was administered in the morning after a fast. |
|
| TAK-792 250 mg | Drug | TAK-792 250 mg was administered in the morning after a fast. |
|
| TAK-792 250 mg placebo | Drug | TAK-792 250 mg placebo was administered in the morning after a fast. |
|
| TAK-792 500 mg | Drug | TAK-792 500 mg was administered in the morning after a fast or after breakfast. |
|
| TAK-792 500 mg placebo | Drug | TAK-792 500 mg placebo was administered in the morning after a fast or after breakfast. |
|
| TAK-792 750 mg | Drug | TAK-792 750 mg was administered in the morning after a fast. |
|
| TAK-792 750 mg placebo | Drug | TAK-792 750 mg placebo was administered in the morning after a fast. |
|
| TAK-792 1250 mg | Drug | TAK-792 1250 mg was administered in the morning after a fast. |
|
| TAK-792 1250 mg placebo | Drug | TAK-792 1250 mg placebo was administered in the morning after a fast. |
|
| Baseline up to Day 5 |
| Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
| Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
| Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
| Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | Day 1: pre-dose and at multiple timepoints (6, 12, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
| AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day -1: pre-dose and Day 1 (2.5 hours post dose) |
| Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose |
| Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose |
TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants.
| BG002 | Cohort 2a: TAK-792 100 mg | TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| BG003 | Cohort 3a: TAK-792 250 mg | TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| BG004 | Cohort 4a: TAK-792 500 mg | TAK-792 500 mg, tablets, orally, once in fasted state (4a-1) on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fed state (4a-2) on Day 1 of another 5-day treatment period. |
| BG005 | Cohort 5a: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state (5a-1), once on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fasted state (5a-2) on Day 1 of another 5-day treatment period. |
| BG006 | Cohort 6a: TAK-792 1250 mg | TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| BG007 | Cohort 4b-6b: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| BG008 | Cohort 4b: TAK-792 500 mg | TAK-792 500 mg, tablets, orally, once in fasted state (4b-1) on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fed state (4b-2) on Day 1 of another 5-day treatment period. |
| BG009 | Cohort 5b: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state (5b-1), once on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fasted state (5b-2) on Day 1 of another 5-day treatment period. |
| BG010 | Cohort 6b: TAK-792 1250 mg | TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| BG011 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Classification | Count of Participants | Participants |
|
| Alcohol Classification | Count of Participants | Participants |
|
| Caffeine Classification | Count of Participants | Participants |
|
| Cohort 2a: TAK-792 100 mg |
TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| OG003 | Cohort 3a: TAK-792 250 mg | TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| OG004 | Cohort 4a-1: TAK-792 500 mg | TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants. |
| OG005 | Cohort 5a-1: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants. |
| OG006 | Cohort 6a: TAK-792 1250 mg | TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| OG007 | Cohort 4a-2: Placebo | TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| OG008 | Cohort 4a-2: TAK-792 500 mg | TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants. |
| OG009 | Cohort 5a-2: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants. |
| OG010 | Cohort 5a-2: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants. |
| OG011 | Cohort 4b-1 - 6b: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| OG012 | Cohort 4b-1: TAK-792 500 mg | TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| OG013 | Cohort 5b-1: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| OG014 | Cohort 6b: TAK-792 1250 mg | TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| OG015 | Cohort 4b-2: Placebo | TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| OG016 | Cohort 4b-2: TAK-792 500 mg | TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| OG017 | Cohort 5b-2: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants. |
| OG018 | Cohort 5b-2: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants. |
|
|
| Primary | Number of Participants With TEAE Related to Vital Signs | Vital signs included body temperature (infra-axillary measurement), supine blood pressure (systolic and diastolic) after the participant has rested for at least 5 minutes, respiratory rate, and pulse (beats per minute [bpm]). | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Day 5 |
|
|
|
| Primary | Number of Participants With TEAE Related to Body Weight | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Day 5 |
|
|
|
| Primary | Number of Participants With TEAE Related to Electrocardiograms (ECG) | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Day 5 |
|
|
|
| Primary | Number of Participants With TEAEs Related to Laboratory Tests | Reported TEAE Related to Laboratory Tests are following; Occult blood positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood glucose increased, Blood triglycerides increased, Blood urine present, Protein urine present, and White blood cell count increased. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Day 5 |
|
|
|
| Primary | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | The gastrointestinal (GI) symptoms (abdominal pain, heartburn, acid regurgitation, hunger pains, nausea, borborygmus, abdominal distension, eructation, increased flatus, constipation, diarrhoea, loose stools, hard stools, urgent need for defecation, and feeling of incomplete evacuation) using GSRS questionnaires at each assessment point. The GSRS a 15-item self-administered questionnaire that assesses the impact of GI symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms. TEAEs related to GSRS were reported as follows: Diarrhoea, Constipation, Faeces hard, and Faeces soft. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to Day 5 |
|
|
|
| Secondary | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
|
|
|
| Secondary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
|
|
|
| Secondary | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Median | Full Range | hours | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
|
|
|
| Secondary | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible. | Posted | Mean | Standard Deviation | percentage (%) of dose | Day 1: pre-dose and at multiple timepoints (6, 12, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
|
|
|
| Secondary | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | micromole*hour per liter (mcmol*hr/L) | Day -1: pre-dose and Day 1 (2.5 hours post dose) |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | micromole per liter (mcmol/L) | Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose |
|
|
|
| Secondary | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Median | Full Range | hour | Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Cohort 1a: TAK-792 30 mg | TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. | 0 | 6 | 1 | 6 |
| EG002 | Cohort 2a: TAK-792 100 mg | TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. | 0 | 6 | 0 | 6 |
| EG003 | Cohort 3a: TAK-792 250 mg | TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. | 0 | 6 | 2 | 6 |
| EG004 | Cohort 4a-1: TAK-792 500 mg | TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants. | 0 | 6 | 0 | 6 |
| EG005 | Cohort 5a-1: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5 days treatment period, in Japanese participants. | 0 | 6 | 1 | 6 |
| EG006 | Cohort 6a: TAK-792 1250 mg | TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. | 0 | 6 | 0 | 6 |
| EG007 | Cohort 4a-2: Placebo | TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants. | 0 | 2 | 0 | 2 |
| EG008 | Cohort 4a-2: TAK-792 500 mg | TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Japanese participants. | 0 | 5 | 0 | 5 |
| EG009 | Cohort 5a-2: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants. | 0 | 2 | 0 | 2 |
| EG010 | Cohort 5a-2: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Japanese participants. | 0 | 6 | 0 | 6 |
| EG011 | Cohort 4b-1 - 6b: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. | 0 | 6 | 3 | 6 |
| EG012 | Cohort 4b-1: TAK-792 500 mg | TAK-792 500 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. | 0 | 6 | 2 | 6 |
| EG013 | Cohort 5b-1: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. | 0 | 6 | 0 | 6 |
| EG014 | Cohort 6b: TAK-792 1250 mg | TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. | 0 | 6 | 2 | 6 |
| EG015 | Cohort 4b-2: Placebo | TAK-792 placebo-matching tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants. | 0 | 2 | 1 | 2 |
| EG016 | Cohort 4b-2: TAK-792 500 mg | TAK-792 500 mg, tablets, orally in fed state, once on Day 1 of 5-day treatment period, in Caucasian participants. | 0 | 6 | 1 | 6 |
| EG017 | Cohort 5b-2: Placebo | TAK-792 placebo-matching tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants. | 0 | 2 | 0 | 2 |
| EG018 | Cohort 5b-2: TAK-792 750 mg | TAK-792 750 mg, tablets, orally in fasted state, fast state was broken immediately after the drug administration, once on Day 1 of 5-day treatment period, in Caucasian participants. | 0 | 6 | 1 | 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
| Alanine aminotransferase increased |
|
| Aspartate aminotransferase increased |
|
| Blood bilirubin increased |
|
| Blood creatine phosphokinase increased |
|
| Blood glucose increased |
|
| Blood triglycerides increased |
|
| Blood urine present |
|
| Protein urine present |
|
| White blood cell count increased |
|
| Constipation |
|
| Faeces hard |
|
| Faeces soft |
|
| M-I |
|
| M-II |
|
| M-I |
|
| M-II |
|
| M-I |
|
| M-II |
|
| M-I |
|
| M-II |
|
| M-I |
|
| M-II |
|
| Day 1: Total BCAA |
|
| Day 1: Total BCAA |
|
| Day 1: Total BCAA |
|