A Phase 1 interventional study of Rifampicin in Tuberculosis, sponsored by National University Hospital, Singapore. Suspended at 1 site in Singapore. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by National University Hospital, Singapore · Phase 1, Interventional, and Treatment
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).
WBA is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial killing. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. This study aims to compare different doses of rifampicin in the WBA model, compare activity of rifampicin on WBA by different mycobacterium tuberculosis strain types and assess the host immune response following drug administration.
1,435 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's planned enrollment of 18 is below the median of 150 across 963 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →National University Hospital, Singapore is the lead sponsor of 451 studies on the registry; 96 are open to participants now.
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10mg/kg Rifampicin
Drug: Rifampicin
20mg/kg Rifampicin
Drug: Rifampicin
30mg/kg Rifampicin
Drug: Rifampicin
Single oral dose of rifampicin
Also known as: Rifampin
Cumulative WBA (reported as change in Mtb log CFU per day)
Time frame: 24 hours
The pharmacokinetic profile of rifampicin
Time frame: 24 hours
Change in host cytokine response after study drug administration
Impact of host immune response before and after drug administration
Time frame: 6 hours following administration
The record gives a start of Feb 2015, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
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This study is suspended, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rifampin
National University Hospital, Singapore →