Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Rifampicin in Healthy Volunteers

NCT02387242 | Suspended Phase 1

• 1 other identifier: High Rif-WBA
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of standard and high doses of rifampicin. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following a single dose of rifampicin at standard dose (10mg/kg) or at high dose (20mg/kg or 30mg/kg).

Conditions

Tuberculosis

Keywords

Tuberculosis; Whole blood Bactericidal Activity; WBA; Rifampicin

Outcome Measures

Primary Outcomes (1)

• Cumulative WBA (reported as change in Mtb log CFU per day)

  24 hours

Secondary Outcomes (1)

• The pharmacokinetic profile of rifampicin

  24 hours

Other Outcomes (1)

• Change in host cytokine response after study drug administration

  6 hours following administration

Study Arms (3)

Group 1

EXPERIMENTAL

10mg/kg Rifampicin

Drug: Rifampicin

Group 2

EXPERIMENTAL

20mg/kg Rifampicin

Drug: Rifampicin

Group 3

EXPERIMENTAL

30mg/kg Rifampicin

Drug: Rifampicin

Interventions

Rifampicin DRUG

Single oral dose of rifampicin

Also known as: Rifampin

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21 and above
• Male or female willing to comply with the study visits and procedures
• Willing and able to provide written informed consent

You may not qualify if:

• Women who are currently pregnant or breastfeeding
• Signs of active TB
• On immunosuppressant, antibiotic or any medication known to have interaction with rifampicin
• Previous allergy to Rifampicin
• Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
• Known hepatic disease or alcohol abuse
• Current use of any other drugs, over the counter medications and herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes
• Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial
• Current participation in other clinical intervention trial or research protocol

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Rifampin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Nicholas Paton

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 12, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

SG (1)