Comparative Bioavailability in Healthy Elderly Volunteers

Alzheimer's Disease Clinical Trial

Official title:

Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253122
• Other study ID #: TRx-037-002
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2010
• Last updated: December 2, 2010
• Start date: February 2010
• Est. completion date: April 2010

Study information

• Verified date: December 2010
• Source: TauRx Therapeutics Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• TRx0037

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
TauRx Therapeutics Ltd	Quotient Clinical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No
Secondary	Safety, tolerability and pharmacokinetics	Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014.		Yes