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Pharmacokinetic evaluation of thiacetazone
C A Peloquin1, A T Nitta, S E Berning
1Department of Medicine, National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado 80206, USA.
Study Objective:
To investigate the steady-state pharmacokinetics of thiacetazone (TB-1), which is active in vitro against Mycobacterium avium complex (MAC).
Design:
Open-label phase I study.
Setting:
Specialized referral hospital.
Patients:
Twelve healthy men and women.
Interventions:
Oral TB-1 150 mg/day was administered for 7 days, followed by blood and urine collection over 48 hours.
Measurements And Main Results:
The serum concentration versus time curves of TB-1 showed sustained concentrations, with maximum values of 1.59 +/- 0.47 micrograms/ml, time to maximum 3.30 +/- 1.18 hours, and serum half-life of 15-16 hours. Less than 25% of TB-1 was recovered unchanged in the urine over 48 hours. Rashes occurred in two subjects at the end of the 7-day dosing period and resolved without progression or sequelae.
Conclusions:
Based on these data, we initiated a phase II study of TB-I in patients with pulmonary MAC infection who do not have the acquired immunodeficiency syndrome.