A First Time in Human Study of GSK586529 in Healthy Volunteers

NCT00703547 | Completed Phase 1

• 1 other identifier: CRZ107432
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

A single blind, randomized, placebo-controlled, crossover study in twenty four healthy male subjects. Subjects will be divided into two cohorts with alternate panel design. The study is investigating the safety, tolerability and pharmacokinetics of single oral escalating doses of GSK586529.

Conditions

Depressive Disorder and Anxiety Disorders

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Secondary Outcomes (2)

• Blood levels of GSK586529 to determine pharmacokinetic parameters

  Pre-dose, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

• Urinary recovery of GSK586529

  Pre-dose, 0-6, 6-12, 12-24, 24-48, 48-72 and 72-96 hours post-dose

Study Arms (2)

Subjects receiving treatment in cohort 1

EXPERIMENTAL

Subjects will receive one of the following sequences; ABDF,BADF, BDAF or BDFA (A=Placebo, B= GSK586529 dose 1 (3 milligrams), D = GSK586529 dose 3, F = GSK586529 dose 5).

Drug: GSK586529 capsules; Drug: GSK586529 tablets; Drug: Placebo

Subjects receiving treatment in cohort 2

EXPERIMENTAL

Subjects will receive one of the following sequences; ACEG,CAEG, CEAG or CEGA (A = Placebo, C= GSK586529 dose 2, E = GSK586529 dose 4, G = GSK586529 dose 6)

Drug: GSK586529 capsules; Drug: GSK586529 tablets; Drug: Placebo

Interventions

GSK586529 capsules DRUG

GSK586529 will be provided as white gelatin capsule with a dose of 3 milligrams.

Subjects receiving treatment in cohort 1; Subjects receiving treatment in cohort 2

GSK586529 tablets DRUG

GSK586529 will be provided as a yellow film-coated tablets for oral administration at three different strengths 10 milligrams, 60 milligrams and 120 milligrams.

Subjects receiving treatment in cohort 1; Subjects receiving treatment in cohort 2

Placebo DRUG

Placebo tablets and capsules will be provided to subjects.

Subjects receiving treatment in cohort 1; Subjects receiving treatment in cohort 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males aged 18-45 years, inclusive.
• Healthy subjects, defined as individuals who are free from clinically significant illness or disease as determined by their (and familial) medical and psychiatric history, physical examination, laboratory studies, and other tests.
• Body weight \>/= 50 kg (110 lbs) and BMI within the range 18.5-29.9 kg/m2 inclusive.
• Demonstrates no evidence of active disease, physical or mental impairment.
• Self-administered Beck Depression Inventory II scale total score no greater than 9, and suicide question score of zero.
• Non-smoker (abstinence from smoking for at least 6 months before the start of the study).
• Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG and a 24 hour Holter ECG).
• Read, comprehend, and write English at a sufficient level to complete study-related materials.

You may not qualify if:

• As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
• The subject has a positive pre-study drug/alcohol screen.
• A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
• The subject has a history of psychiatric illness.
• Any history of suicidal attempts or behavior.
• Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units..
• Consumption of grapefruit juice or grapefruit within 14 days prior to the first dose of study medication.
• Any subject who is not prepared to eat the standard meals provided by the clinic or is a vegetarian.
• Any history of an endocrine disorder including, but not limited to, diabetes or disorders of the hypothalamus, pituitary, adrenal, or thyroid glands, or gonadal disorder or dysfunction of the reproductive organs.
• Clinically significant abnormal; total and free testosterone, LH, FSH, ACTH or cortisol, or TSH or T4 values at screening/baseline
• LFTs elevated
• Any other clinically significant laboratory abnormality
• The subject has a screening ECG with parameters outside ranges defined in the protocol will also be excluded.
• History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
• The subject has received an investigational drug or participated in any other research trial within 3 months or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of study medication.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7NS, United Kingdom

Location

Related Links

• Results for study CRZ107432 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: June 23, 2008
• Study Start: January 28, 2008
• Primary Completion: April 11, 2008
• Study Completion: April 11, 2008
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

GB (1)