Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
|ClinicalTrials.gov Identifier: NCT01131351|
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : July 2, 2012
The purpose of this study is:
- To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily (BID) to MDR TB patients refractory to treatment with an optimized background regimen of anti-TB medications (OBR).
- To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Drug: OPC-67683||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multi-center, Non-controlled, Open-label Dose Escalation Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Orally Administered OPC-67683 Two Times Daily to Patients With Pulmonary Multidrug-Resistant Tuberculosis Refractory to Conventional Treatment|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Dosage-500-800 mg Strength 250-400 mg Frequency b.i.d.
- Vital signs [ Time Frame: 9 months ]blood pressure, heart rate, respiratory rate, body temperature and body weight
- Clinical Laboratory Assessments [ Time Frame: 9 months ]Hematology, chemistry, and urinalysis
- Standard 12-lead ECG [ Time Frame: 9 months ]
- Reported Adverse Events [ Time Frame: 9 months ]
- PK assessments [ Time Frame: 12 months ]Pharmacokinetics parameters including maximum observed plasma concentration (Cmax), time to maximum plasma concentration (tmax), lowest plasma concentration during the 24 hours postdose (Cmin), and area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24h) at various time points.
- Sputum Culture Conversion [ Time Frame: 24 weeks ]Efficacy evaluation of sputum culture conversion including proportion of patients with sputum culture conversion at Day 168 evaluated with MGIT® culture system and solid media
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131351
|Infectology Center of Latvia - Clinic of Tuberculosis and Lung Diseases|
|Tinuzi Ogre District, Latvia, LV 5015|
|Hospital for Tuberculosis and Lung Diseases|
|Siauliai, Lithuania, LT-76231|
|National Tuberculosis and Infectious Diseases University Hospital|
|Vilnius, Lithuania, LT-10214|