Multiple Dose Study of TRx0037

Launched by TAURX THERAPEUTICS LTD · Dec 2, 2010

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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