Single Ascending Dose Study Using DS-1971 to Assess Safety, Tolerability, and Pharmacokinetics in Healthy Participants.
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|ClinicalTrials.gov Identifier: NCT02107885|
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : December 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Safety Tolerability Pharmacokinetics||Drug: DS-1971 Drug: placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1, Double-blind, Randomized, Placebo-controlled Single Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DS-1971a in Healthy Male Subjects|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
single ascending dose of 5mg, 10mg, 30mg, 90mg, 250mg, 500mg, 1000mg, 1500mg.
6 subjects in each group will receive DS-1971.
Placebo Comparator: placebo
placebo matching each of the DS-1971 dosages.
2 subjects in each group will receive placebo.
- safety and tolerability adverse events [ Time Frame: 20 days after dose ]determine number, type, and severity of adverse events
- safety and tolerability physical exam [ Time Frame: 20 days after dose ]determine adverse changes in vital signs, ECG.
- safety and tolerability laboratory blood and urine tests [ Time Frame: from day 1 through 20 days after dose ]determine adverse changes in laboratory safety tests of blood (biochemistry and haematology) and urine.
- plasma concentration AUC [ Time Frame: day 4 ]concentration in blood measured as Area under the curve (AUC)
- maximum blood concentration [ Time Frame: day 4 ]Cmax
- time of maximum blood concentration [ Time Frame: day 4 ]T_max
- half-life of drug in body [ Time Frame: day 4 ]T_1/2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107885
|Hammersmith Medicines Research Ltd.|
|London, United Kingdom, NW10 7EW|