Title
Comparative Bioavailability in Healthy Elderly Volunteers
Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers
Phase
Phase 1Lead Sponsor
TauRx Therapeutics LtdStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Alzheimer's DiseaseIntervention/Treatment
trx0037 ...Study Participants
24A randomised four way crossover design in which each subject will receive two dose levels of TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised order.
Inclusion Criteria: Male and female 55 and over No clinically important abnormal physical finding No clinically significant lab results Normal ECG, Normal BP and HR,BMI between 19 and 32 Weight 50 to 100 kg, Able to communicate Provide written informed consent Non smokers Males to use contraception Females to be surgically sterile or post menopausal Exclusion Criteria: Administration of any IMP other than study drug within 12 weeks before entry Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol Surgical or medical condition that might interfere with IMP History of drug or alcohol abuse Clinically significant allergy requiring treatment Loss of greater than 400ml of blood within 12 weeks. Serious adverse reaction or hypersensitivity to any drug Prescence of Hep B, Hep c or HIV-1 or HIV-2 at screening Presence of G6PD at screening History of methaemoglobinaemia Partner who is pregnant of lactating Positive Pregnancy test
