Multiple Dose Study of TRx0037

Alzheimer's Disease Clinical Trial

Official title:

A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253499
• Other study ID #: TRx-037-003
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2010
• Last updated: December 16, 2010
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: December 2010
• Source: TauRx Therapeutics Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2010
• Est. primary completion date: May 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• TRx0037
75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.

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	Bioavailability	The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population.	19 Days (7-10 day follow up)	No
Primary	Pharmacokinetics	The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.	19 Days (7-10 day follow up)	No
Primary	Safety and tolerability	Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037	19 Days (7-10 day follow up)	Yes