Trial record 10 of 28 for:    " November 02, 2011":" December 02, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects

This study has been completed.
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01467531
First received: November 3, 2011
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.


Condition Intervention Phase
Infections, Human Immunodeficiency Virus and Hepatitis
Drug: Dolutegravir
Drug: Rlipivirine
Drug: GSK1265744
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1, Open-Label, Crossover Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Composite of Pharmacokinetic Parameters following Dolutegravir administration with and without rilpivirine [ Time Frame: Cohort 1: Period 1 and 3 on Day 5: pre-dose, 1, 2, 3, 4, 8, 12 and 24 hours post dose. ] [ Designated as safety issue: No ]
    Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC(0-tau)), Maximum observed concentration (Cmax), Time of occurrence of Cmax (tmax), Pre-dose (trough) concentration at the end of the dosing interval (Ctau)

  • Composite of Pharmacokinetic Parameters following GSK1265744 administration with and without rilpivirine [ Time Frame: Cohort 2: Period 2 and 3, Day 12: pre-dose, 1, 2, 3, 4, 5, 6, 9, 12, 16, and 24hrs post dose. ] [ Designated as safety issue: No ]
    steady state, AUC(0-t), Cmax, tmax, and Ctau

  • Composite of Pharmacokinetic Parameters following rilpivirine administration with and without Dolutegravir [ Time Frame: Cohort 1: Period 2, Day 11: pre-dose, 1, 2, 3, 4, 5, 6, 9, 12, 16, and 24hrs post dose. Period 3: Day 5 pre-dose 1, 2, 3, 4, 5, 6, 9, 12, 16, and 24hrs post dose ] [ Designated as safety issue: No ]
    steady state, AUC(0-tau), Cmax, tmax, and Ctau

  • Composite of Pharmacokinetic Parameters following rilpivirine administration with and without GSK1265744 [ Time Frame: Cohort 2: Periods 1 and 3: Day 12: pre-dose, 1, 2, 3, 4, 8, 12 and 24hrs post dose ] [ Designated as safety issue: No ]
    AUC(0-tau), Cmax, tmax, and Ctau


Secondary Outcome Measures:
  • Safety and tolerability parameters, including the collection of all adverse events [ Time Frame: 42 days or final visit has occurred ] [ Designated as safety issue: No ]
    Collected from first dose to final visit.

  • Safety and tolerability parameters, including the collection of any concurrent medication from first dose to final visit [ Time Frame: 42 days or final visit has occurred ] [ Designated as safety issue: No ]
    Collected from first dose to final visit.

  • Safety and tolerability parameters, including change from baseline in clinical laboratory tests (hematology, chemistry, urinalysis) assessments [ Time Frame: 42 days or final assessment has occurred ] [ Designated as safety issue: No ]
  • Safety and tolerability parameters, including change from baseline in ECG assessments [ Time Frame: 42 days or final assessment has occurred ] [ Designated as safety issue: No ]
  • Safety and tolerability parameters, including change from baseline in vital signs assessments [ Time Frame: 42 days or final assessment has occurred ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Period 1 Treatment A = Dolutegravir 50mg q24h x 5 days; Period 2 Treatment B = Rilpivirine 25mg q24h x 11; Period 3 Dolutegravir 50mg q24h + Rilpivirine q24h x 5 days
Drug: Dolutegravir
50mg q 24h
Other Name: GSK1349572
Drug: Rlipivirine
25mg q24h
Other Name: Edurant
Experimental: Cohort 2
Period 1 Treatment A = GSK1265744 30mg q24h x 12 days; Period 2 Treatment B = Rilpivirine 25mg q24h x 12; Period 3 GSK1265744 30mg q24h + Rilpivirine q24h x 12 days
Drug: Rlipivirine
25mg q24h
Other Name: Edurant
Drug: GSK1265744
30mg q24h

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Healthy as determined by a responsible and experienced 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 the Investigator feels that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
  • Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
  • A female subject is eligible to participate 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.
  • Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol.
  • Body weight greater than or equal to 50 kg for males and 45 kg for females and BMI within the range 18.5- 31.0 kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A positive pre-study drug/alcohol screen.
  • A positive test for HIV antibody.
  • History of regular alcohol consumption within 6 months of the study as defined in the protocol.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first 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 the first dose of study medication, 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 study medications, 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.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Pregnant females as determined by positive urine hCG test at screening or prior to dosing.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • History or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467531

Locations
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
ViiV Healthcare
Shionogi
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided by ViiV Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01467531     History of Changes
Other Study ID Numbers: 116181
Study First Received: November 3, 2011
Last Updated: October 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ViiV Healthcare:
HIV, GSK1265744, GSK1349572, dolutegravir, rilpivirine, drug interaction, pharmacokinetics

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections

ClinicalTrials.gov processed this record on July 24, 2014