GW823296 Repeat Dose Study In Healthy Male And Female Subjects

NCT00675116 | Completed Phase 1

• 1 other identifier: 110371
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate the safety, tolerability and pharmacokinetics of GW823296 following 28 days, once-daily repeat oral doses.

Conditions

Healthy Subjects

Keywords

safety,; healthy volunteers,; GW823296,; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Adverse Events, Concomitant Medication,

Secondary Outcomes (1)

• Physical Examination, Neurological Examination, Eye Examination, 12-lead ECG, Vital Signs, Laboratory Parameters, Pharmacokinetic Parameters

Interventions

GW823296 DRUG

Eligibility Criteria

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

You may not qualify if:

• Male or female between 18 and 65 years of age inclusive.
• A female subject is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and confirmed by screening follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml or \<140 pmol/L.. Females on hormone replacement therapy (HRT) must discontinue HRT and their post-menopausal status confirmed as per above tests prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they are not allowed to use HRT during the study.
• Child-bearing potential and agrees to use one of the contraception methods as per protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 7 days after the last dose of study medication.
• Male subjects must agree to use one of the contraception methods as per protocol. This criterion must be followed from the time of the first dose of study medication until at least 7 days post last dose.
• No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview (M.I.N.I) scale.
• Normal neurological examination performed by the study neurologist
• A 12-lead ECG at screening showing no abnormalities that in the opinion of the Principal Investigator will compromise safety in this study.
• Body weight \>/ 50 kg and BMI within the range 19.0 - 29.9 kg/m2 (inclusive).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• The subject must be able to read, comprehend and record information.
• A signed and dated written informed consent is obtained from the subject
• The subject is available to complete the study
• As a result of any of the medical interview, physical examination or screening investigations the Physician Responsible considers the subject unfit for the study.
• The subject or his/her family has a history of a drug or other allergy which in the opinion of the Physician Responsible contraindicates the participation in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: May 8, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 15, 2010

Record last verified: 2010-10

Locations

AU (1)