Dose Escalation Study of SQ109 in Healthy Adult Volunteers
Tracking Information | |
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First Received Date ICMJE | March 19, 2009 |
Last Updated Date | November 3, 2011 |
Start Date ICMJE | April 2009 |
Primary Completion Date | November 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Safety and tolerability evaluated by a review of physical examinations, color and visual acuity tests, funduscopic examinations, neurological examinations, vital signs assessments, 12-lead ECGs, routine clinical laboratory tests, and AE assessments. [ Time Frame: Duration of study. ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00866190 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
Serial blood samples for the measurement of the plasma levels of SQ109 will be collected. Pharmacokinetic variables will be assessed. [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7-13 (Cohorts 1 and 3), 9 and 10 (Cohort 2 only), 14, 15, 16, 17, 18, 21, and 28. ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE |
Serial blood samples for the measurement of the plasma levels of SQ109 will be collected. Pharmacokinetic variables will be assessed. [ Time Frame: Prior to and following single and multiple doses of SQ109. Trough PK samples are to be collected just prior to study drug administration. ] [ Designated as safety issue: No ] |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Dose Escalation Study of SQ109 in Healthy Adult Volunteers |
Official Title ICMJE | A Phase 1B, Randomized, Placebo-Controlled, Double-Blinded, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single-Daily Doses of SQ109 in Normal, Healthy Male and Female Volunteers |
Brief Summary | The purposes of this study are to determine: how safe it is to take SQ109 (an experimental tuberculosis treatment) once a day by mouth for up to 2 weeks in 2 different dosages; how well the body accepts it; how SQ109 enters and leaves the body and blood tissues over time; the amounts that can be detected in the blood; and how long it stays in the body. The study involves 30 volunteers: 24 will receive SQ109 and 6 will receive placebo (inactive substance). Qualified participants will be admitted to the study unit within 28 days from the screening and stay as inpatient for approximately 2 weeks. During this period they will receive study drug and complete all scheduled procedures including multiple blood draws. After discharge, there is a 14 day follow up period. Total study participation is about 56 days. |
Detailed Description | Tuberculosis (TB) is one of the most important global health problems. According to recent estimates from the World Health Organization, 8 million new cases of TB and 1.9 million deaths from TB occur annually, making TB the second leading cause of death from an infectious pathogen. Due to multidrug resistant TB, the need for new and more effective drugs to treat TB is well recognized. This study is a phase 1B, prospective, single-center, double-blinded, randomized, placebo-controlled, clinical study of SQ109 to evaluate single-daily dose tolerability and pharmacokinetics (PK) of oral SQ109 in healthy subjects. The objectives of the study are to: determine the safety and tolerability of SQ109 administered daily for 14 days in healthy male and female volunteers; assess single dose and multiple dose PK of SQ109 administered daily for 14 days in healthy male and female volunteers; and assess single dose and multiple dose PK of SQ109 administered twice per week after a 5-day loading regimen in healthy, male and female volunteers. A total of 30 subjects, ages 18-45, will be enrolled in the study, allocated equally among 3 cohorts of 10 subjects each, 8 treated with active drug and 2 with placebo. Subjects in Cohorts 1 and 3 will receive an oral dose of 75 mg or 150 mg, respectively, of study medication daily for 14 days. Subjects in Cohort 2 will receive 150 mg daily for 5 days followed by 2 additional doses of 150 mg on Days 9 and 14. Subject participation will include a screening visit within 28 days of study entry, a 14 day in-patient treatment period, and a 14 day out-patient follow-up phase. Safety will be assessed by study personnel continually during the 14 day in-patient treatment period and the out-patient follow-up phase. Adverse events will be recorded for all subjects. Other safety measures include laboratory tests, electrocardiograms (ECGs), visual and neurological assessments, physical examinations, and vital signs. Study duration will be approximately 6 months. Subject participation duration will be 56 days. |
Study Type ICMJE | Interventional |
Study Phase | Phase 1 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Condition ICMJE | TB Multi-drug Resistant |
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 10 |
Completion Date | November 2009 |
Primary Completion Date | November 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years to 45 Years |
Accepts Healthy Volunteers | Yes |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00866190 |
Other Study ID Numbers ICMJE | 08-0048, N01AI80024C, SQ-109 |
Has Data Monitoring Committee | |
Responsible Party | Director ORA, HHS/NIAID/DMID |
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) |
Verification Date | October 2009 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |