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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis. If single doses are safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy volunteers and patients with pulmonary tuberculosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo |
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| 10 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo |
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| 20 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo |
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| 50 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo |
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| 100 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo |
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| 200 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SQ109 | Drug | Single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Compared to baseline measurements: Change in Hb, Hct, WBC count / differential, platelet count Change in serum chemistry parameters Change in visual acuity Alteration in color perception Changes in cranial, sensory or motor nerve function, and mental status (as defined by the mini mental status examination) Prolongation in QTc interval, and rhythm changes by electrocardiogram | daily examinations for 7 days after single dose drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of SQ109 in fasted subjects and effect of high-fat, high calorie meal on pharmacokinetics | maximum serum concentration (Cmax) Time to Cmax (Tmax) Area under the curve (AUC) Volume of Distribution (Vz/F) Oral clearance (CL/F) | pK samples collected for 96 hours post dose administration |
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Inclusion Criteria:
Subject must be 18 to 55 years of age.
Subject must be a healthy male or female volunteer (i.e., hematology, coagulation,clinical chemistries and urinalysis tests must be within normal, allowable limits).
Clinical laboratory tests must be performed within 21 days of receiving first dose of study drug.
Body weight must be ± 20% of the ideal for height and estimated frame based on the 1983 Metropolitan Life Insurance Company table.
Subject must give voluntary written informed consent before any study related procedure is performed.
Female subjects will be postmenopausal, surgically sterile, or agree to use two forms of contraception from screening through 30 days after the dose of study drug. All female subjects of childbearing potential must have a negative urine pregnancy test at screening.
Male subjects must agree to use an acceptable barrier method for birth control from screening through 30 days after the dose of study drug.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Phaes 1 Clinical Study Unit | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| 300 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo |
|
| Food effect group | Experimental | 6 Subjects received single, 300 mg SQ109 after high-fat, high-calorie meal. |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |