Pharmacokinetics of Lamivudine at Two Different Doses

NCT00985647 | Completed Phase 1 DMC

• 1 other identifier: NCHECR-ENCORE2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to measure the pharmacokinetics (how a drug is absorbed, distributed and eliminated from the body) of lamivudine (3TC) and its active component after 3TC is given at two different doses, 300mg and 150mg once daily.

Conditions

HIV Infections

Keywords

HIV; HAART; ART; Pharmacokinetic; Healthy volunteers; 3TC; Lamivudine

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of 3TC and intracellular concentrations of its active anabolite 3TC-TP as measured by the Area Under the Curve (AUC 0-24h).

  Concentrations will be compared after the administration of 3TC 300 mg and 150 mg once daily.

  Measured over 24 hours at the end of each 10-day dosing period.

Secondary Outcomes (1)

• Safety and tolerability of 3TC following the administration of 3TC 300 mg and 150 mg once daily

  Assessed at regular intervals throughout the study

Study Arms (2)

3TC 300mg/150mg

ACTIVE COMPARATOR

Group 1: Participants will be administered 3TC 300 mg once daily orally for 10 days. A 10 day wash-out period will follow (days 11-20). From day 21, participants will be administered 3TC 150 mg once daily for 10 days

Drug: Lamivudine (3TC)

3TC 150mg/300mg

ACTIVE COMPARATOR

Group 2: Participants will be administered 3TC 150 mg once daily orally for 10 days. A 10 day wash-out period will follow (days 11-20). From day 21, participants will be administered 3TC 300 mg once daily for 10 days

Drug: Lamivudine (3TC)

Interventions

Lamivudine (3TC) DRUG

3TC 300mg/150mg participants will receive 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days. 3TC 150mg/300mg participants will receive 3TC 150 mg (1 x 150 mg tablet) once daily for 10 days, washout for 10 days and then 3TC 300 mg (2 x 150 mg tablet) once daily for 10 days.

Also known as: Epivir

3TC 150mg/300mg; 3TC 300mg/150mg

Eligibility Criteria

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

You may qualify if:

• The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
• Male or non-pregnant, non-lactating females
• Between 18 to 65 years, inclusive
• Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive
• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study.

You may not qualify if:

• Any significant acute or chronic medical illness
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
• Positive blood screen for hepatitis B core and/or C antibodies and/or hepatitis B surface antigen
• Positive blood screen for HIV-1 and/or 2 antibodies
• Current or recent (within 3 months) gastrointestinal disease
• Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
• Exposure to any investigational drug or placebo within 3 months of first dose of study drug
• Use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs
• Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
• Previous allergy to any of the constituents of the pharmaceuticals administered in this trial.

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (1)

St Stephen's Centre, Chelsea and Westminster Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Marta Boffito, MD PhD

  Chelsea and Westminster Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 11, 2011

Record last verified: 2011-02

Locations

GB (1)