NCT05691660|CompletedPhase 1
A Study of TAS3731 in Healthy Adults
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults
Sponsor study identifier
interventional
238
1 country
1
Study Start
January 17, 2023
Actual (reported)Primary Completion
May 21, 2024
Actual (reported)Study Completion
May 21, 2024
Actual (reported)To evaluate the safety of single and repeated administration of TAS3731.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 21, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 24, 2022
Actual (reported)January 17, 2023
Actual (reported)January 20, 2023
Actual (reported)May 21, 2024
Actual (reported)May 21, 2024
Actual (reported)The number and incidence rate of adverse events
Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
The number and incidence rate of adverse drug reactions
Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16
Evaluation of Systolic and Diastolic blood pressure
Single dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 7 days, Repeated dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 16 days
Evaluation of pulse rate
Single dose cohort：Change from Baseline pulse rate at 7 days, Repeated dose cohort：Change from Baseline pulse rate at 16 days
Evaluation of body temperature
Single dose cohort：Change from Baseline body temperature at 7 days, Repeated dose cohort：Change from Baseline body temperature at 16 days
Number of participants with abnormal laboratory values
Single dose cohort：Change in number of participants with abnormal laboratory values between baseline and 7 days, Repeated dose cohort：Change in number of participants with abnormal laboratory values between baseline and 16 days
Evaluation of QT interval corrected for heart rate using Fridericia's formula(QTcF) interval
Single dose cohort：Change from Baseline QTcF interval at 7 days, Repeated dose cohort：Change from Baseline QTcF interval at 16 days
Evaluation of RR-interval
Single dose cohort：Change from Baseline Evaluation of RR-interval at 7 days, Repeated dose cohort：Change from Baseline Evaluation of RR-interval at 16 days
Oral administration,1 day,QD
Oral administration,7 days,QD
A site selected by Taiho Pharmaceutical Co., Ltd.
Tokyo, Japan
Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Co., Ltd.
238 participants (actual enrollment reported by the registry).
First Submitted
November 24, 2022
First Posted
January 20, 2023
Study Start
January 17, 2023
Actual (reported)Oral administration,7 days,BID
Oral administration, 1 day,QD
Oral administration, 7 days,QD
Oral administration, 7 days,BID
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 21, 2024
Actual (reported)Study Completion
May 21, 2024
Actual (reported)Last Updated
August 14, 2024
Record last verified: 2024-08
Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical\_trial\_information\_disclosure\_policy/index.html.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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