NCT00352066

Brief Summary

The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2006

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

1 month

First QC Date

July 12, 2006

Last Update Submit

June 21, 2011

Conditions

HIV Infection

Keywords

Human Immunodeficiency Virusanti-retroviral therapynucleoside analoguereverse transcriptaseapricitabinetipranavirbioequivalencedrug-drug interactionpharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • To compare the single dose pharmacokinetics of apricitabine when administered alone and in the presence of steady state concentrations of tipranavir 500 mg administered twice daily in combination with ritonavir 200 mg twice daily.

    day 1 and day 10

Secondary Outcomes (2)

  • To compare the steady state pharmacokinetics of tipranavir 500 mg administered twice daily with ritonavir 200mg in the presence and absence of apricitabine.

    day 9 and day 10

  • To evaluate the safety and tolerability of apricitabine administered in combination with tipranavir and ritonavir.

    day 10

Interventions

apricitabineDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males 18-40 years old
  • non-smokers
  • no clinically significant medical history

You may not qualify if:

  • current or relevant previous medical history of significance
  • hepatitis B, hepatitis C, or HIV positive
  • current use of prescription or OTC medications
  • use of illicit substances or alcohol (\>14 drinks/week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jasper Clinic Inc

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

apricitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Susan W Cox, Ph D

    Avexa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 12, 2006

First Posted

July 14, 2006

Study Start

July 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

US(1)