Pharmacokinetic Study for Anti-tuberculosis Drugs

Pulmonary Tuberculosis Clinical Trial

— TBPK  

Official title:

A Single-Center, Open-Label, Randomized, Crossover Design Study to Evaluate the Effect of Dietary Status on Pharmacokinetic Profile of Orally Administered First-Line Anti-TB Drugs in Subjects With Pulmonary Tuberculosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00948077
• Other study ID #: 2009WFCRC-08
• Secondary ID: 98040
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2009
• Last updated: April 11, 2011
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: April 2011
• Source: Taipei Medical University WanFang Hospital
• Contact: Ming-Chih MC Yu, M.D.
• Phone: +886-2-29307930
• Email: yutbc[@]ms10.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of food on pharmacokinetic profile of multiple doses orally administered first-line anti-tuberculosis drugs in subjects with pulmonary tuberculosis.

Description:

This is a single-center, open-label, randomized, two way crossover design, pharmacokinetics study.

1. Treatment A: study agents (Rifater+EMB) will be given approximately 45 minutes prior to breakfast.

2. Treatment B: study agents (Rifater+EMB) will be given approximately 45 minutes after the breakfast is finished.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than 20 years

2. Karnofsky score of > 50

3. Clinical and radiographic signs and symptoms consistent with pulmonary TB determined by the investigator.

4. A documented positive microbiology diagnosis results which indicate highly suspected pulmonary tuberculosis.

5. Anti-TB drugs treatment with of ethambutol, isoniazid, rifampin and pyrazinamide.

6. Willing to be hospitalized per standard of care for at least 6 days from first does of anti-TB drugs administered.

7. Start anti-TB chemotherapy for at least 2 days prior to participate in the study.

8. The subject is able to understand and comply with protocol requirements, and follow the instructions and protocol-stated restrictions.

9. Only subjects who have provided signed and dated written informed consent will be included.

Exclusion Criteria:

1. Previously treated for MDR-TB, XDR-TB or likely to require surgical procedure for management of TB

2. Alcohol or drug abuse that would interfere with the ability to meet study requirements (in the opinion of investigator)

3. Concomitant disorders or conditions for which ethambutol, isoniazid, rifampin or pyrazinamide are contraindicated.

4. Unable to meet selected safety criteria obtained at screening (Laboratory parameters, etc.)

5. Women who are Pregnant or breastfeeding during the study period.

6. Subjects with a known allergy to study drugs

7. In the opinion of the investigator to be unsuitable for study participation for any reason.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• Rifater and EMB
The main difference between Treatment A and Treatment B is the time of taking drugs, so the intervention of this study belongs to a behavioral intervention. The patients assigned randomly the Arm "Treatment A" on the fifth day will be switched to the Arm "Treatment B" on the sixth day. On the other hand, the patients assigned randomly the Arm "Treatment B" on the fifth day will be switched to the Arm "Treatment A" on the sixth day. The flow of intervention is drawn as below. Treatment A (5th day) ---> Treatment B (6th day) ; Treatment B (5th day) ---> Treatment A (6th day)

Locations

Country	Name	City	State
Taiwan	Taipei Medical University- Wan Fang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum concentration (Cmax)of first-line TB drugs		Before and 1, 2, 4, 6 and 10 hours after dosing	Yes
Secondary	N-acetyltransferase 1 and 2 (NAT 1 and 2), which effects the metabolism of anti-TB drugs, would be examined.		Before taking the anti-TB drugs on the fifth day	Yes