Phase IC Study of Safety and PK of SQ109 300mg Daily

NCT01358162 | Completed Phase 1

• 2 other identifiers: 09-0111N01AI80024C
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the safety and tolerability and pharmacokinetics.

Conditions

Tuberculosis

Keywords

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Safety & tolerability via: physical exams, color and visual acuity tests, funduscopic exams, neurological exams, vital signs, electrocardiograms, routine clinical labs (includes chemistry, hematology, coagulation and urinalysis data), and adverse events.

  Days 1-14, 16-18, 21 and 28

Secondary Outcomes (15)

• Pharmacokinetics of SQ109: Serial blood samples prior to and following single/multiple doses: AUC(0-t): area under the concentration time curve to the last time with concentration greater than or equal to the validated limit of quantitation of the assay

  Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on day 1.

• Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: AUC(0-infinity): area under the concentration time curve to infinity

  Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on day 1.

• Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: AUC(0-24): area under the concentration time curve to 24 hours

  Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.

• Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: t1/2: apparent terminal half-life

  Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1 & 14.

• Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: CL/F: apparent oral clearance

  Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.

Study Arms (2)

SQ109

EXPERIMENTAL

300 mg of SQ109, orally, given daily for 14 consecutive days

Drug: SQ109

Placebo

PLACEBO COMPARATOR

Placebo given orally, daily for 14 consecutive days

Other: Placebo

Interventions

Placebo OTHER

Placebo given orally, daily for 14 consecutive days

Placebo

SQ109 DRUG

A single oral dose of 300 mg of SQ109 given daily for 14 consecutive days.

SQ109

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, coagulation, clinical chemistries and urinalysis tests must be within study-defined ranges (See Appendix B). Clinical tests must be performed within 28 days of receiving first dose of study drug.
• Body Mass Index (BMI) must be between 18 and 30 kg/m2 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; or
• diaphragm in combination with contraceptive jelly, cream, or foam; or
• spermicide; or
• 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 advice and recommend use of additional birth control (as in criterion 6 above) 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.
• Subject agrees to comply with all study requirements, including clinic house rules.

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 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 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 HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody and/or a positive history for alcohol abuse or dependence and/or a positive serum ethanol or a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, marijuana, opiates, phencyclidine (PCP)).
• Subject has a baseline QTcF interval \>450 msec (males) or \>470 msec (females) (defined in Section 9.1.3) or a family history of prolonged QTcF 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 having active TB 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 \>/=100 degrees F or \>/= 37.7 degrees C).
• 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

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: May 23, 2011
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 14, 2013

Record last verified: 2011-05

Locations

US (1)