Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Primary Completion Date :||May 2011|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|