Trial record 17 of 32 for:    " September 24, 2008":" October 24, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

GSK1349572 Drug Interaction Study With Protease Inhibitors

This study has been completed.
Sponsor:
Collaborator:
Shionogi
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00774735
First received: October 16, 2008
Last updated: September 9, 2010
Last verified: September 2010
  Purpose

A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and the HIV protease inhibitors lopinavir/ritonavir and darunavir/ritonavir


Condition Intervention Phase
Healthy Subjects
Infection, Human Immunodeficiency Virus
Drug: GSK1349572
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase I, Open Label, Randomized, Two Period, One-way Two Sequence Crossover Study to Evaluate the Effect of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK1349572 Pharmacokinetics in Healthy Adult Subjects (ING111405).

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Plasma GSK1349572 steady-state AUC(0-tau), Cmax, Ctau, and Cmin following administration of GSK1349572 30 mg q24h for 5 days and following co-administration with LPV/RTV 400/100 mg q12h or DRV/RTV 600/100 mg q12h for 14 days. [ Time Frame: 19 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, ECG, and vital signs assessments. [ Time Frame: 14 Days after last dose ] [ Designated as safety issue: Yes ]
  • Plasma LPV, DRV, and RTV PK parameters, including AUC(0-t), Cmax, and Cmin following co-administration of GSK1349572 30 mg q24h and LPV/RTV 400/100 mg q12h or DRV/RTV 600/100 mg q12h for 14 days. [ Time Frame: 19 Days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 Drug: GSK1349572
30 mg given in combination with lopinavir/ritonavir
Experimental: Sequence 2 Drug: GSK1349572
30 mg in combination with darunavir/ritonavir

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
  • Male or female between 18 and 65 years of age.
  • A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
  • Is pre-menopausal with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or
  • Is post-menopausal defined as 12 months of spontaneous amenorrhea. A follicle stimulating hormone (FSH) level will be performed to confirm a post-menopausal status. For this study, FSH levels > 40 mlU/ml is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt, HRT should be discontinued for 2 weeks and then the subject rescreened, as HRT can suppress FSH.
  • Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication.
  • Body weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index (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:

  • 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.
  • 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)
  • 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.
  • 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.
  • If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
  • History of regular alcohol consumption within 6 months of the study defined as:
  • An average weekly intake of >14 drinks/week for men or >7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
  • Has a history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
  • Pregnant females as determined by positive serum or urine human chorionic gonadotrophin (hCG) test at screening or prior to dosing.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy should be excluded.
  • History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease.
  • History/evidence of clinically significant pulmonary disease.
  • History of significant renal or hepatic diseases.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • A positive test for HIV antibody.
  • Serum creatinine values greater than the upper limit of normal. A single repeat is allowed for eligibility determination.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100 bpm for male subjects.
  • ECG criteria outside protocol limits.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774735

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

Publications:
Goffinet C, Allespach I, Oberbremer L, et al. Pharmacovirological impact of an integrase inhibitor on HIV-1 cDNA species in vivo . Cold Spring Harbor Laboratory - 34th Annual Meeting on Retroviruses. 2009;
Song I, Min S, Borland J, et al. The effect of ritonavir-boosted protease inhibitors (PIs) on the HIV integrase inhibitor, S/GSK1349572, in healthy Chemotherapy; September 12-15, 2009; San Francisco, CA. Abstract A1-1304.

ClinicalTrials.gov Identifier: NCT00774735     History of Changes
Other Study ID Numbers: 111405
Study First Received: October 16, 2008
Last Updated: September 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
healthy volunteer
darunavir
lopinavir
ritonavir
GSK1349572
integrase
pharmacokinetics

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
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
Protease Inhibitors
Ritonavir
Lopinavir
Darunavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014