Multiple Dose Study of TRx0037
|ClinicalTrials.gov Identifier: NCT01253499|
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: TRx0037||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers|
|Study Start Date :||March 2010|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics
75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.
- Bioavailability [ Time Frame: 19 Days (7-10 day follow up) ]The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population.
- Pharmacokinetics [ Time Frame: 19 Days (7-10 day follow up) ]The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.
- Safety and tolerability [ Time Frame: 19 Days (7-10 day follow up) ]Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253499
|Principal Investigator:||Stuart Dr Mair, MBChB||Quotient Clinical|