Dose Escalation Study of SQ109 in Healthy Adult Volunteers

NCT00866190 | Completed Phase 1

• 3 other identifiers: 08-0048N01AI80024CSQ-109
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

TB Multi-drug Resistant

Keywords

Mycobacterium tuberculosis, SQ109

Outcome Measures

Primary Outcomes (1)

• 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.

  Duration of study.

Secondary Outcomes (1)

• Serial blood samples for the measurement of the plasma levels of SQ109 will be collected. Pharmacokinetic variables will be assessed.

  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.

Study Arms (3)

Cohort 1

EXPERIMENTAL

SQ109 dose 75 mg or placebo once daily for 14 days.

Drug: SQ109; Drug: Placebo

Cohort 3

EXPERIMENTAL

SQ109 dose 150 mg or placebo once daily for 14 days.

Drug: SQ109; Drug: Placebo

Cohort 2

EXPERIMENTAL

SQ109 dose 150 mg or placebo once daily on Days 1-5, 9, and 14.

Drug: SQ109; Drug: Placebo

Interventions

SQ109 DRUG

SQ109 150 mg is an oval, coated, white, scored tablet. Dosages: 75 mg administered once daily for 14 days; 150 mg administered once daily on Days 1-5, 9, and 14; and 150 mg administered once daily for 14 days.

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Placebo is an oval, coated, white, scored tablet administered once daily for 14 days or on Days 1-5, 9, and 14.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must be 18 to 45 years of age (inclusive).
• Subject must be a healthy male or female volunteer (i.e., hematology, clinical chemistries and urinalysis tests must be within study-defined ranges. Clinical tests must be performed within 28 days of receiving first dose of study drug.
• Body Mass Index (BMI) must be between 18.0 and 30.0 kg/m\^2 inclusive.
• Subject must be Tuberculin Skin Test/Purified Protein Derivative (TST/PPD) negative (within the previous 1 year) at Screening. The TST/PPD may be omitted if the subject presents written evidence of having a negative test during the previous 12 months.
• Subject must be able to give voluntary written informed consent before any study related procedure is performed.
• If female, has no childbearing potential or agrees to avoid becoming pregnant from the day of screening through their entire participation in the trial (Day 28) by using one of the following acceptable methods of birth control plus recommended use of a barrier method (condom) by the male partner (even if vasectomized):
• intrauterine contraceptive device
• diaphragm in combination with contraceptive jelly, cream, or foam
• spermicide
• abstinence
• Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy or status after hysterectomy.
• Hormonal contraceptives of any type or form (including oral, transdermal, vaginal or depot preparations) will not be allowed during the study.
• All female subjects of childbearing potential must have a negative serum pregnancy test at screening and within 24 hours of the first dose of study product.
• Male subjects must agree to use an acceptable barrier method for birth control (abstinence or use of a condom with spermicide) from screening through Study Day 28 and advise and recommend use of additional birth control to female sex partners throughout the study.
• Subject agrees not to donate blood during the study and up to 30 days after Study Day 28.

You may not qualify if:

• A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principal Investigator (PI), would jeopardize the safety of the subject or impact the validity of the study results.
• Subject has been on an abnormal diet during the 4 weeks preceding the study. Abnormal diet is defined as a diet in which the subject has a significant change in eating habits (e.g., liquid diet only) and an unbalanced diet (e.g., protein only, high fat, low carbohydrate, etc.).
• Subject has received an investigational drug in a clinical trial within 30 days prior to study initiation.
• Subject has used any over-the-counter (OTC) medication, including vitamins and herbal supplements, within 7 days prior to Day 1 of the study, unless in the opinion of the PI, the substance would not likely impact on the conduct of this study, including pharmacokinetics (PK) of SQ109.
• Subject has used any prescription medication within 14 days prior to Day 1 of the study, or the use of hormonal preparations containing sex hormones within 30 days prior to Day 1 of the study.
• Subject has any current medical condition requiring treatment with medication, either prescription or OTC.
• Subject has been treated with any known CYP450 enzyme altering drugs such as azoles, antifungals, barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to Day 1 of the study.
• Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody and/or a positive urine screen for alcohol or drugs of abuse.
• Subject has a baseline QTc interval \>450 msec (males) or \>470 msec (females) or a family history of prolonged QTc syndrome or premature cardiac death.
• Subject has Wolf Parkinson White Syndrome (WPW) or family history of WPW or a history of supra-ventricular tachycardias or syncope.
• Subject has lived with a person with active tuberculosis (TB) with the past 12 months or has traveled to an area of endemic TB within the past 12 months.
• Subject has an abnormal result on the Ishihara color test, the funduscopic exam, current optic neuritis or known retinal disease.
• Subject has an uncontrolled intercurrent illness (i.e., active infection) or fever (oral temperature greater than or equal to 100.0 degrees Fahrenheit or greater than or equal to 37.7 degrees Celsius).
• Subject has had major surgery within 4 weeks of study entry.
• Women who are pregnant or breastfeeding.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Quintiles Phase I Services

Overland Park, Kansas, 66211, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 7, 2011

Record last verified: 2009-10

Locations

US (1)