Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02448719 | Single-Dose Phase 1 Study of TAK-792 | PHASE1 | COMPLETED | 72 | — | — | May 27, 2015 | Jan 28, 2016 | Mar 19, 2019 | 1 | Japan |
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 \[bpm\]).
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 | 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 |
| Name | Type | Description |
|---|---|---|
| TAK-792 30 mg | DRUG | TAK-792 30 mg was administered in the morning after a fast. |
| 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. |
Inclusion Criteria: 1. In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of ...