GSK706769/KALETRA Drug-drug Interaction Study

NCT00723775 | Completed Phase 1

• 1 other identifier: CRR110744
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and without KALETRA (LPV 400 mg/RTV 100mg) q12h

Conditions

Infection, Human Immunodeficiency Virus

Keywords

KALETRA; GSK706769; HIV; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• GSK706769 PK

  Part 1: 4 days; Part 2; 25 days

Secondary Outcomes (5)

• GSK706769 safety parameters, including adverse events, clinical laboratory, ECG, and vital signs assessments.

  Part 1: 4 days; Part 2; 25 days

• Plasma GSK706769 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.

  Part 1: 4 days; Part 2; 25 days

• Plasma metabolite GSK1996847 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.

  Part 1: 4 days; Part 2; 25 days

• Metabolite GSK1996847 AUC(0-t) and Cmax following repeat dose administration of GSK706769 QD for 10 days and following coadministration with Kaletra (LPV 400mg/RTV 100mg) q12h for 14 days.

  Part 1: 4 days; Part 2; 25 days

• Plasma protein and mRNA expression levels of biomarkers before and after administration of GSK706769 QD for 5 days.

  Part 1: 4 days; Part 2; 25 days

Study Arms (2)

Part 1

OTHER

GSK706769 new vs. current formulation; GSK706769 alone vs. GSK706769 plus Kaletra

Drug: GSK706769 & KALETRA

Part 2

OTHER

GSK706769 alone for 10 days; GSK706769 + Kaletra for 14 days

Drug: GSK706769 & KALETRA

Interventions

GSK706769 & KALETRA DRUG

GSK706769 alone and GSK706769 + Kaletra

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
• Male or female between 18 and 50 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 females with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or hysterectomy;
• 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. Following confirmation of their post-menopausal status, they can resume use of HRT.
• 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 medication.
• Body weight \>= 50 kg (110 lbs.) for men and \>=45 kg (99 lbs) for women 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.

You may not qualify if:

• As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
• 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.
• Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
• 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.
• Note: 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.
• Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final pharmacokinetic sample during each treatment period.
• History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
• 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.
• 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.
• 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).
• The subject has received GSK706769 in a previous clinical trial.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

Related Links

• Results for study CRR110744 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

lopinavir-ritonavir drug combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 29, 2008
• Study Start: July 24, 2008
• Primary Completion: November 8, 2008
• Study Completion: November 8, 2008
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)