Loading clinical trials...

First Time in Human Study (FTIH) With Positron Emission Tomography (PET) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

First Time in Human Study (FTIH) With Positron Emission Tomography (PET)

A Single-blind, Randomised, Placebo-controlled, Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1144814 in Healthy Male and Female Subjects and an Open-label Positron Emission Tomography Study in Healthy Male Subjects to Evaluate the Neurokinin-1 (NK1) Receptor Occupancy of GSK1144814 in the Living Human Brain Using 11C GR205171.

NCT01381419•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study described in the present protocol consists of two sections. Part A is the first administration into man to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of GSK1144814. The study is a single-blind, randomised, placebo-controlled design in healthy male and female (of non-childbearing potential) subjects. Part B will be an open-label design in healthy male subjects to assess the GSK1144814 neurokinin-1 (NK1) receptor occupancy by positron emission tomography (PET) scanning with \[11C\]-GR205171

Detailed Description

GSK1144814 is a dual neurokinin-1 (NK1) and neurokinin-3 (NK3) antagonist with the potential to treat schizophrenia \& depression. This study described in the present protocol consists of two sections. Part A is the first administration into man to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of GSK1144814. The study is a single-blind, randomised, placebo-controlled design in healthy male and female (of non-childbearing potential) subjects. Part B will be an open-label design in healthy male subjects to assess the GSK1144814 NK1 receptor occupancy by positron emission tomography (PET) scanning with \[11C\]-GR205171.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
•Male or female aged between 18 and 55 years (inclusive) for Part A, or male aged between 25 and 55 years (inclusive) for Part B.
•A female subject is eligible to participate in Part A 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 (in questionable cases a blood sample with simultaneous follicle stimulating hormone \[FSH\] \>40 mIU/mL and oestradiol \<40 pg/mL \[\<140 pmol/L\] is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood sampling; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume the use of HRT during the study without the use of a contraceptive method.
•A male subject must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the first investigational product dosing day until at least 3 months after receiving the last dose of the investigational product.
•Body weight ≥50 kg and body mass index (BMI) within the range 18 to 29.9 kg/m2 (inclusive).
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•QTcB or QTcF \<450 msec.
•Demonstrates no evidence of mental impairment or co-morbid psychiatric disorders.

Exclusion Criteria

•The subject has a positive pre-study drug/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 (HBsAg) or positive hepatitis C virus (HCV) antibody test result within 3 months of Screening.
•A positive test result for antibodies to human immunodeficiency virus (HIV)-1/2.
•Significant renal abnormality (from medical history or as indicated by laboratory investigations. In addition, subjects with idiopathic haematuria or proteinuria or conditions such as benign orthostatic proteinuria and benign familial haematuria should be excluded from the study).
•History of regular alcohol consumption within 6 months of the study start defined as:
•• An average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.
•The subject has participated in a clinical trial and has received an investigational product within 3 month prior to the first investigational product dosing day in the current study.
•Exposure to more than four new chemical entities within 12 months prior to the first investigational product dosing day.
•Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to receiving the first dose of the investigational product, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
•History of sensitivity to any of the investigational products, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation in the study.
+6 more criteria

Locations (1)

GSK Investigational Site

Harrow, Middlesex, United Kingdom

Key Dates

Start Date

October 20, 2008

Primary Completion Date

April 1, 2009

Completion Date

April 1, 2009

Last Updated

July 7, 2017

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

GSK1144814

DRUG

GSK1144814

DRUG

GSK1144814

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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: July 7, 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

First Time in Human Study (FTIH) With Positron Emission Tomography (PET)

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

Brain Stimulation to the Hippocampus in Schizophrenia