Multiple Dose Study of TRx0037

NCT01253499 | Completed Phase 1

• 1 other identifier: TRx-037-003
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• 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)

• Pharmacokinetics

  The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.

  19 Days (7-10 day follow up)

• 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)

Study Arms (1)

TRx0037

EXPERIMENTAL

Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics

Drug: TRx0037

Interventions

TRx0037 DRUG

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

TRx0037

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TauRx Therapeutics Ltd: lead
• Quotient Clinical: collaborator

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Stuart Dr Mair, MBChB

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 3, 2010
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 17, 2010

Record last verified: 2010-12