NCT05680792

Brief Summary

The goal of this study is to

  1. 1.determine the most effective biological sampling method that best describe the pharmacokinetics nitazoxanide/tizoxanide and to;
  2. 2.evaluate the clinical significance of the pharmacokinetics interaction between nitazoxanide (1000mg twice daily) and atazanavir/ritonavir (300mg/100mg).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

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

September 10, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

December 7, 2022

Last Update Submit

September 11, 2023

Conditions

Drug Interaction

Keywords

Nitazoxanideatazanavir/ritonavirdrug-drug interaction

Outcome Measures

Primary Outcomes (6)

  • Minimum plasma concentration (Cmin)

    Tizoxanide minimum plasma concentration with or without atazanavir/ritonavir

    After the first dose (Day 1)

  • Minimum plasma concentration (Cmin)

    Tizoxanide minimum plasma concentration with or without atazanavir/ritonavir

    At Day 5

  • Maximum plasma concentration (Cmax)

    Tizoxanide maximum plasma concentration with or without atazanavir/ritonavir

    After the first dose (Day 1)

  • Maximum plasma concentration (Cmax)

    Tizoxanide maximum plasma concentration with or without atazanavir/ritonavir

    At Day 5

  • Area under the concentration-time curve (AUC)

    Tizoxanide Area under the concentration-time curve with or without atazanavir/ritonavir

    After the first dose (Day 1)

  • Area under the concentration-time curve (AUC)

    Tizoxanide Area under the concentration-time curve with or without atazanavir/ritonavir

    At Day 5

Study Arms (2)

Administration of nitazoxanide alone

OTHER

Participants in this arm will receive 1000 mg of nitazoxanide tablets alone

Drug: Nitazoxanide

Administration of nitazoxanide plus atazanavir/ritonavir

OTHER

Participants in this arm will receive 1000 mg of nitazoxanide tablets twice daily together with one tablet of atazanavir/ritonavir (300 mg/100 mg) once daily in the morning.

Drug: NitazoxanideDrug: Atazanavir/ritonavir

Interventions

NitazoxanideDRUG

1000 mg nitazoxanide tablets twice daily. The drug will be administered after meal for 5 days

Also known as: Netazox
Administration of nitazoxanide aloneAdministration of nitazoxanide plus atazanavir/ritonavir
Atazanavir/ritonavirDRUG

300/100 mg atazanavir/ritonavir tablets in the evening once daily, to be administered after meal for 5 days.

Administration of nitazoxanide plus atazanavir/ritonavir

Eligibility Criteria

Age18 Years - 41 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The study population will include both male and female healthy volunteers that are eighteen years or above
  • non-smokers, non-alcoholics, had not taken any medication or coffee 2 weeks before participating, were non-pregnant and non-breastfeeding

You may not qualify if:

  • Pregnant women will be excluded from the study. Moreover, volunteers who have been on any other drugs in the last two weeks will also be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obafemi Awolowo University

Ile-Ife, Osun State, 220101, Nigeria

Location

MeSH Terms

Interventions

nitazoxanideatazanavir, ritonavir drug combination

Study Officials

  • Babatunde A Adeagbo, PhD

    Obafemi Awolowo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2022

First Posted

January 11, 2023

Study Start

September 10, 2020

Primary Completion

January 10, 2023

Study Completion

January 31, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

NG(1)