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GW679769

Phase 3

Nausea and Vomiting, Postoperative | Small molecule | Other |GSK plc|Last Updated: Sep 25, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment482

FDA Designations

No designations recorded

Clinical trial landscape

GW679769 · 14 trials · 13 indications

Phase 3 1Phase 2 10Phase 1 3
NCT00326248Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In WomenNausea and Vomiting, Postoperative
COMPLETED482 Analytics
PHASE3COMPLETED
Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women
Nausea and Vomiting, Postoperative
NCT00326248482
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Study Endpoints

Primary Endpoints

Rates of vomiting and retching
after surgery
Comparison of GW679769 and placebo when taken daily in the morning, on the time needed to fall asleep at bedtime on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic.
9 Days
Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep.
28 Days
Comparison of GW679769 and placebo on the average time needed to fall asleep after bedtime dosing on two consecutive nights, as assessed by electroencephalography and other physiological changes during sleep.
48 Hours
To identify whether GW679769 has an effect on gastric accommodation to a meal, as measured by gastric barostat in male and female patients with FD. Meal induced fundus relaxation as measured by gastric barostat.
Three to Five Days
Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs
12 weeks
Change in score on a Depression rating scale following 8 weeks of treatment.
The proportion of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, & no premature discontinuation from the study) during the first 72 hr evaluation period following the emergence from anesthesia.
72 Hours
Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.
Mean Wake time after sleep onset (WASO) derived from PSG recording
Night 1 and 2 of each treatment period (Approximately up to 31 Days)

WASO was measured from persistent sleep onset to lights on. It was calculated as number of wake epochs from persistent sleep onset to lights on divided by 2. WASO measures was analyzed using a mixed effect model with session and treatment as fixed effect and participants as random effect.

Plasma levels for casopitant will be measured in Period 1 at Day 1 to 3 and in Period 2 at Day 8. Plasma levels for rifampin will be measured in Period 2 at Day 8 to 10.
Up to Day 10
Change in images of the brain, when stimulated, after once daily dosing for 12 weeks with GW679769, comparator or placebo in subjects with SAD.
Area under the concentration-time curve (AUC) of single oral dose of GW679769 in healthy subjects
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Blood samples for pharmacokinetics (PK) analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.

AUC of multiple oral dose of GW679769 in healthy subjects
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.

AUC of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.

AUC of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration.

Maximum observed concentration (Cmax) of single oral dose of GW679769 in healthy subjects
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.

Cmax of multiple oral dose of GW679769 in healthy subjects
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.

Cmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.

Cmax of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration.

AUC of single oral dose of GSK525060 in healthy subjects
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.

AUC of multiple oral dose of GSK525060 in healthy subjects
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.

AUC of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.

AUC of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration.

Cmax of single oral dose of GSK525060 in healthy subjects
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration.

Cmax of multiple oral dose of GSK525060 in healthy subjects
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration

Cmax of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours

Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration.

Cmax of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment
Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours

Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration.

Secondary Endpoints

Rates of nausea. Blood test results.
after surgery
Comparison of GW679769 and placebo on total sleep time and time awake after initial sleep onset on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic. Daily sleep questionnaires and mental functioning tests on Days 1 and 9 of treatment.
9 Days
Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination.
28 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
GW679769EXPERIMENTAL120mg once a day
PlaceboPLACEBO_COMPARATORPlacebo once a day
Treatment Period 1EXPERIMENTALSubject will receive single oral dose of 150 milligram (mg) of Casopitant. There will be wash out period of 7 days.
Treatment Period 2EXPERIMENTALSubjects will receive rifampin 600 mg once daily on Days 1 - 9. On Day 8 subjects will receive a single dose of oral casopitant 150 mg along with rifampin.
Healthy subjects receiving GW679769EXPERIMENTALHealthy Subjects will receive single 100 milligram (mg) oral doses of GW679769 for five consecutive days.
Subjects with hepatic impairment receiving GW679769EXPERIMENTALSubjects with hepatic impairment will receive single 100 mg oral doses of GW679769 for five consecutive days.

Interventions

NameTypeDescription
GW679769 (casopitant)DRUG -
GW679769DRUG -
GW679769 oral tabletsDRUG2x GW679769 60mg tablets
PlaceboDRUGPlacebo oral tablets to match experimental intervention
DexamethasoneDRUG -
Ondansetron HydrochlorideDRUG -
GW679769 (Casopitant) oral tabletsDRUGCasopitant tablets will be available with dose strength of 50 mg. Subjects will receive three 50 mg tablets for the dose of 150 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.
Rifampin oral capsulesDRUGRifampin capsules will be available with dose strength of 300 mg. Subjects will receive two 300 mg capsules for the dose of 600 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites58

Inclusion criteria: * History of PONV and/or motion sickness. * Have not smoked for the last 6 months. * Having certain types of abdominal, breast or shoulder surgeries. Exclusion criteria: * Pregnant or breastfeeding. * Taking certain medications. * Have certain pre-existing medical conditions.

Countries:United StatesCanadaFranceGermanyHong KongHungaryIrelandPakistanPhilippinesThailandUnited KingdomBelgiumArgentinaChileCosta RicaItalyPeruPolandSlovakiaSpainSwedenDenmarkIsraelNorwaySloveniaAustriaCroatiaCzechiaGreeceMexicoPortugalRussiaSingaporeTaiwan
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Frequently asked questions about GW679769

What is GW679769 used for?

GW679769 is an investigational small molecule being studied for sleep initiation and maintenance disorders, including primary insomnia. It was evaluated in Phase 2 clinical trials for its effects on sleep onset, sleep maintenance, and next-day functioning in adults and the elderly with primary insomnia.

Who makes GW679769?

GW679769 is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company sponsored four Phase 2 clinical trials of the drug, all of which have been completed.

What phase is GW679769 in?

GW679769 is in Phase 2 clinical development. All four of its clinical trials were Phase 2 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is GW679769 in?

GW679769 has completed four Phase 2 trials: NCT00280423, NCT00280436, NCT00354809, and NCT00650871. These studies evaluated the drug's effects on sleep onset, maintenance, and next-day functioning in subjects with primary insomnia, including elderly and non-elderly populations.

How does GW679769 work?

GW679769 is a small molecule developed for psychiatric use. Its specific molecular target has not been disclosed in the available clinical trial information. The drug was studied for its effects on sleep initiation and maintenance in patients with primary insomnia.