Multiple Dose Study of TRx0037

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: TauRx Therapeutics Ltd
• Collaborator: Quotient Clinical

Criteria

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

• Presence 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