NCT02792686

Brief Summary

This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).

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 healthy-volunteers

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

May 30, 2016

Last Update Submit

May 16, 2024

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients experiencing at least one Adverse Event

    Up to 45 days post dosing

Secondary Outcomes (2)

  • Peak Plasma Concentrations (Cmax) of ABX464 and metabolite

    Up to 45 days post dosing

  • Area Under the Curve (AUC) of Plasma Concentrations of ABX464 and metabolite

    Up to 45 days post dosing

Study Arms (1)

ABX464

EXPERIMENTAL

50, 100, 150 or 200 mg once a day / Single Administration

Drug: ABX464

Interventions

ABX464DRUG

Single Administration

ABX464

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers
  • Subject in good health on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG) and routine laboratory safety tests
  • Subject with a BMI of 18 27kg/m²
  • Non smokers or light smokers of less than 10 cigarettes per day
  • Having given their written informed consent

You may not qualify if:

  • Subject with any on-going infection or disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Cap

Montpellier, France

Location

Related Publications (1)

  • Scherrer D, Rouzier R, Noel Barrett P, Steens JM, Gineste P, Murphy RL, Tazi J, Ehrlich HJ. Pharmacokinetics and tolerability of ABX464, a novel first-in-class compound to treat HIV infection, in healthy HIV-uninfected subjects. J Antimicrob Chemother. 2017 Mar 1;72(3):820-828. doi: 10.1093/jac/dkw458.

    PMID: 27999038DERIVED

MeSH Terms

Interventions

ABX464

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 7, 2016

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 17, 2024

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)