Alzheimer's Disease
Conditions
Brief summary
A 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.
Interventions
DRUGTRx0037
Sponsors
Quotient Clinical
TauRx Therapeutics Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative bioavailability | — | Investigate the relative bioavailability of TRx0037 and TRx0014 at two molar equivalent doses in healthy elderly male and female (post-menopausal/non-childbearing) subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety, tolerability and pharmacokinetics | — | Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014. |
Outcome results
None listed