NCT03284164

Brief Summary

This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2017

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

First Submitted

Initial submission to the registry

September 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

September 28, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
Last Updated

June 6, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

September 8, 2017

Last Update Submit

June 5, 2018

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers

    Measuring Cmax : the peak plasma concentration

    up to six days post dose

Secondary Outcomes (2)

  • Evaluation of the adverse events for TXL in RI subjects

    up to six days post dose

  • Evaluation of safety labs for TXL in RI subjects

    up to six days post dose

Study Arms (2)

Healthy Subjects

EXPERIMENTAL

Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)

Drug: Tenofovir Exalidex (TXL)

Severe RI

EXPERIMENTAL

Severe Renal Impairment subjects Tenofovir Exalidex (TXL)

Drug: Tenofovir Exalidex (TXL)

Interventions

Tenofovir Exalidex (TXL)DRUG

Drug: Tenofovir Exalidex (TXL)

Also known as: lipid conjugate TFV
Healthy SubjectsSevere RI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 years of age and over
  • Capable of giving written informed consent
  • Capable of completing study requirements

You may not qualify if:

  • Positive result for HIV, HBV, or HCV
  • History or medical condition which could impact patient safety
  • Current or past abuse of alcohol or drugs
  • Participation in another clinical trial within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • John Sullivan-Bolyai, MD, MPH

    ContraVir Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Tenofovir exalidex (TXL)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 15, 2017

Study Start

September 28, 2017

Primary Completion

January 17, 2018

Study Completion

February 20, 2018

Last Updated

June 6, 2018

Record last verified: 2018-02

Locations

US(1)