Loading clinical trials...

COMPLETEDPHASE1

Study to Assess the Effect of Food on the Concentration of GW273225 in the Body of Healthy Male and Female Volunteers

An Open, Randomised, Two-period Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of GW273225 Administered Immediately After Food and Administered in Fasted State to Healthy Male and Female Subjects

NCT00501865•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The rationale of this study is to assess whether or not food affects the absorption of GW273225 into the blood of healthy male and female volunteers in order to evaluate whether or not this drug should be given at a certain time relative to the consumption of food.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male or female subjects aged 18-55 years, inclusive.
•Body weight 45-100kg and BMI 19-29.9 kg/m2 inclusive.
•Post-menopausal females (longer than two years). Or Pre-menopausal females with a documented hysterectomy and/or bilateral oophorectomy, the latter only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
•Female subjects of child bearing potential willing to participate commit to use a double-barrier method of contraception. One of the following methods is acceptable as the sole method of contraception if there is indisputable data that it is \>99% effective, otherwise it should be used with a barrier method (condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository): Documented tubal ligation. Documented placement of an IUD or IUS. Male partner sterilisation prior to the female subject's entry into the study and is the sole partner for that female subject.
•No abnormality on relevant clinical examination or clinical chemistry or haematology examination at the pre-study medical examination.
•A normal 12-lead ECG at the pre-study medical examination
•A negative pre-study Hepatitis B, Hepatitis C, and HIV antibody result at screening.
•A negative pre-study urine drug screen.
•A negative screen for alcohol.
•Subjects must smoke \<10 cigarettes per day.
+1 more criteria

Exclusion Criteria

•An unwillingness of the male subject to use a double-barrier method of contraception.
•Female subject is pregnant or lactating.
•Female subjects using hormonal contraceptive precautions including progesterone-coated IUD and oral contraceptives.
•Female subjects using hormonal replacement therapy.
•History of alcohol/drug abuse or dependence within 12 months of the study
•The subject has a positive pre-study urine drug/ urine alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
•A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
•Weekly alcohol intake of more than 21 units or an average daily intake of greater than three units (for male subjects) or weekly alcohol intake more than 14 units or an average daily intake of greater than two units (for female subjects).
•The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication.
•Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
+6 more criteria

Locations (1)

GSK Investigational Site

Cambridge, Cambridgeshire, United Kingdom

Key Dates

Start Date

August 6, 2007

Primary Completion Date

October 11, 2007

Completion Date

October 11, 2007

Last Updated

August 4, 2017

Enrollment

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

GW273225

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Assess the Effect of Food on the Concentration of GW273225 in the Body of Healthy Male and Female Volunteers

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

CBT-CP for Veterans With SMI

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Early Intervention for Youth at High Risk for Bipolar Disorder