NCT00618241

Brief Summary

The purpose of this study is to determine whether interactions between raltegravir and lamotrigine take place and to study the safety of the combination raltegravir/lamotrigine before used in HIV patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 19, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 19, 2020

Status Verified

May 1, 2011

Enrollment Period

8 months

First QC Date

February 5, 2008

Last Update Submit

October 16, 2020

Conditions

HIV Infection

Keywords

interactionsneuropathic painpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of lamotrigine, lamotrigine-2N-glucuronide, and raltregravir

    just before dosing, at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 24 hours and 48 hours after dosing on study days 4-5 and 32-33.

Secondary Outcomes (1)

  • Determination of pharmacokinetic parameters (AUC, Cmax, Tmax, Cmin and T 1/2) by noncompartmental analysis

    at each sampling time

Study Arms (2)

A

EXPERIMENTAL

Group A: day 1-5 Raltegravir 400 mg oral BD (twice daily). Lamotrigine one oral dose 100 mg on day 4. Wash-out 6-31. Followed by one oral dose Lamotrigine 100 mg on day 34. 5 days Raltegravir 400 mg oral BD. Lamotrigine one oral dose 100mg on day 34.

Drug: lamotrigineDrug: Raltegravir

B

ACTIVE COMPARATOR

Group B: day 4 Lamotrigine one oral dose on day 4. Wash-out day 6-28 followed by Raltegravir 400 mg oral BD day 29-33. One dose Lamotrigine 100 mg oral on day 32. One dose Lamotrigine 100 mg oral.

Drug: lamotrigineDrug: Raltegravir

Interventions

lamotrigineDRUG

100 mg

Also known as: Lamictal
AB
RaltegravirDRUG

400 mg BD

AB

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 55 years of age
  • Subject does not smoke more than 10 cigarettes, 2 cigars or 2 pipes per day
  • Subject has a Quetelet Index of 18 to 30 kg/m2
  • Subject is able and willing to sign informed consent
  • Subject is in good age-appropriate health condition
  • Subject has a normal blood pressure and pulse rate

You may not qualify if:

  • History of sensitivity/idiosyncrasy to medicinal products or excipients
  • Positive HIV test
  • Positive hepatitis B or C test
  • Therapy with any drug (2 weeks preceding dosing) except for paracetamol
  • Relevant history or presence of pulmonary disorders, cardiovascular
  • History of or current abuse of drugs, alcohol or solvents
  • Inability to understand the nature and extent of the trial and procedures
  • Participation in a drug trial within 60 days prior to the first dose
  • Donation of blood within 60 days prior to the first dose
  • Febrile illness within 3 days before the first dose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Location

Related Publications (1)

  • van Luin M, Colbers A, Verwey-van Wissen CP, van Ewijk-Beneken-Kolmer EW, van der Kolk M, Hoitsma A, da Silva HG, Burger DM. The effect of raltegravir on the glucuronidation of lamotrigine. J Clin Pharmacol. 2009 Oct;49(10):1220-7. doi: 10.1177/0091270009345689. Epub 2009 Aug 28.

    PMID: 19717722RESULT

Related Links

MeSH Terms

Conditions

HIV InfectionsNeuralgia

Interventions

LamotrigineRaltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolidinonesPyrrolidines

Study Officials

  • David M. Burger, PharmD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 19, 2008

Study Start

February 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 19, 2020

Record last verified: 2011-05

Locations

NL(1)