Healthy Adult Subjects
Conditions
Brief summary
A Phase 1, Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending and Multiple Dose of TS-172 in Healthy Adult Subjects
Interventions
DRUGTS-172
* Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting) * Multiple dose of TS-172 90 mg before breakfast and dinner
DRUGPlacebo
* Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2) * Multiple dose of TS-172 placebo before breakfast and dinner
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. Japanese healthy males aged 20 years or older but less than 40 years at the time of informed consent 2. Those with a BMI of 18.5 or more and less than 25.0 at screening test 3. Those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.
Exclusion criteria
1. Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator. 2. Those who correspond to any of the following about bowel movements; * Repeated diarrhea (Bristol Stool Form Score \[BSFS\] score of 6 or higher) on a daily basis * Repeated constipation (no defecation for 2 days or more in a week) on a daily basis 3. Those who correspond to any of the following about bowel movements in the 7 days before administration; * Diarrhea on 2 or more days in 7 days * 2 or more days without a bowel movement in 7 days 4. Those who have a history of gastrointestinal ulceration 5. Those who correspond to any of the following about infection; * Positive for SARS-CoV-2 in the nucleic acid amplification test performed at the time of admission * Suspected of having COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and serious AEs (SAEs) | Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily Bristol Stool Form Scale (BSFS) | Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11 | BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool |
| Concentration of unchanged form in plasma, urine and stool | Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11 | — |
| Area under the plasma concentration-time curve (AUC) of unchanged form | Part A: Day 1 up to Day 4, Part B: Day 1 up to Day 11 | — |
| Mean daily urinaly excretion of sodium and phosphorus | Part A (Step 1): Day 1 up to Day 8, Part A (Step 2, 3, 4): Day 1 up to Day 4, Part B: Day 1 up to Day 11 | — |
Countries
Japan
Outcome results
None listed