Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

NCT00358813 | Completed Phase 1

• 1 other identifier: NKT102783
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to evaluate how subjects with mild or moderate kidney problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.

Conditions

Vomiting

Keywords

emesis; renal impairment; GW679769; kidney problems

Outcome Measures

Primary Outcomes (2)

• Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060

  Blood samples will be collected at the indicated time points for pharmacokinetic analysis.

  Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5

• Maximum observed concentration (Cmax) of casopitant and GSK525060

  Blood samples will be collected at the indicated time points for pharmacokinetic analysis.

  Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5

Secondary Outcomes (11)

• Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060

  Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5

• Half-life of casopitant and GSK525060

  Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5

• Free fraction (percent unbound) of casopitant and GSK525060

  1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5

• Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

  Up to Day 22

• Number of subjects with abnormal values for blood pressure

  Up to Day 22

Study Arms (1)

Subjects receiving casopitant

EXPERIMENTAL

Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.

Drug: Casopitant

Interventions

Casopitant DRUG

Casopitant oral tablets will be available with a dose of 50 milligrams.

Also known as: GW679769

Subjects receiving casopitant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy or have mild or moderate renal impairment.
• Females must be of non-childbearing potential(hysterectomy, bilateral oophorectomy, post-menopausal) OR childbearing and must have a negative pregnancy test and meet/comply with one of the following: abstinence, double-barrier contraception, vasectomized partner).
• Be negative for Hepatitis B and C.
• Have negative results on drug, alcohol and HIV tests.
• Have stable renal function.

You may not qualify if:

• Have a peptic ulcer.
• Abuse drugs or alcohol.
• Are pregnant or lactating.
• Have heart failure.
• Have uncontrolled emesis.
• Have an infection.
• Have taken or received inducers or inhibitors of CYP3A4 or CYP3A5 within 14 days of study start.
• Active peptic ulcer disease.
• Digoxin use.
• Laboratory results that show low iron or pepsinogen levels, AST and CK level \>1,5 ULN, or that show stool is positive for occult blood.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Miramar, Florida, 33025, United States

Location

GSK Investigational Site

Orlando, Florida, 32809, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study NKT102783 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Vomiting; Renal Insufficiency

Interventions

casopitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: September 8, 2006
• Primary Completion: August 22, 2008
• Study Completion: August 22, 2008
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (3)