Effects of SQ109 on QTc Interval in Healthy Subjects

NCT01874314 | Withdrawn Phase 1

• 2 other identifiers: 11-0079HHSN272200800026C
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single center, open label, crossover study to evaluate the safety and tolerability of multiple dose levels of SQ109.

Conditions

Tuberculosis

Keywords

tuberculosis, SQ109, QTc, moxifloxacin, crossover, placebo, pharmacokinetic, randomized, single-center

Outcome Measures

Primary Outcomes (2)

• Solicited and unsolicited adverse events, including symptoms, physical findings, laboratory testing, holter monitor and ECG changes for 300mg/day SQ109

  Days 1-7 of each dosing period and 30 days after last dosing period.

• Electrocardiogram and holter monitor data (QTc, T wave forms, QRS, RR and PR intervals) for 300mg/day SQ109

  Days 1-7 of each dosing period and 30 days after last dosing period.

Secondary Outcomes (3)

• Solicited and unsolicited adverse events, including symptoms, physical findings, laboratory testing, holter monitor and ECG changes for 450mg/day SQ109

  Days 1-7 of each dosing period and 30 days after last dosing period.

• Pharmacokinetics of SQ109 at doses of 300 or 450mg/day; AUC0-, (Cmax), time to maximum concentration (Tmax), elimination rate constant, elimination half-life, clearance, volume of distribution, and urinary excretion

  Day 1 and Day 6 of each dosing period

• Electrocardiogram and holter monitor data (QTc, T wave forms, QRS, RR and PR intervals) for 450mg/day SQ109

  Days 1-7 of each dosing period and 30 days after last dosing period.

Study Arms (4)

SQ109 450 mg

EXPERIMENTAL

Single daily dose of oral 450mg SQ109 for 7 days.

Drug: SQ109

Moxifloxacin

ACTIVE COMPARATOR

Single daily dose of oral 400mg moxifloxacin for 7 days followed by 7 days washout period.

Drug: Moxifloxacin

SQ109 Placebo

PLACEBO COMPARATOR

Single daily dose of oral SQ109 placebo for 7 days followed by 7 days washout period.

Other: SQ109 Placebo

SQ109 300 mg

EXPERIMENTAL

Single daily dose of oral 300mg SQ109 for 7 days followed by 7 days washout period.

Drug: SQ109

Interventions

SQ109 DRUG

300mg or 450mg of SQ109 administered orally, once daily for 7 days.

SQ109 300 mg; SQ109 450 mg

SQ109 Placebo OTHER

Placebo is a round, coated, yellow, unscored tablet. SQ109 Placebo administered orally, once daily for 7 days.

SQ109 Placebo

Moxifloxacin DRUG

400mg of moxifloxacin (positive control) administered orally, once daily for 7 days.

Moxifloxacin

Eligibility Criteria

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

You may qualify if:

• Men and women aged 18 to 45 years, inclusive.
• Ability to understand the consent process and procedures.
• Informed consent obtained and signed.
• Comprehension of the study objectives and procedures which will be determined by the recruiter using a series of questions after explaining the procedures.
• Subject agrees to be available for all study visits and is able to comply with protocol requirements for the entire duration of the study.
• Subject agrees not to participate in another clinical trial at any time during the study period.
• Subjects who have a body mass index (BMI) \>/=18 kg/m\^2 and \</= 35 kg/m\^2
• General good health, without current medical illness or clinically significant abnormal physical examination findings that classify the subject as other than healthy as determined by study investigators
• Negative serum pregnancy test at screening and a negative urine pregnancy test on the day of admittance to the inpatient phase for all female subjects of child bearing potential.
• Negative urine toxicity screen for alcohol, marijuana, cocaine metabolite, amphetamines, opiates, PCP, barbiturates, and benzodiazepines.
• Agreement by subjects with reproductive potential to use an adequate method of contraception during the study and for 90 days after study drug administration. Female subjects must agree to the use of two reliable methods of contraception while receiving study drug and for 90 days after study drug administration, which can include: condoms, spermicidal gel, diaphragm, hormonal or non-hormonal intrauterine device, surgical sterilization, oral contraceptive pill, and depot progesterone injections. If a male subject is heterosexually active, the subject and his partner must use at least two forms of the listed contraceptive methods.

You may not qualify if:

• Note that individuals with a history of cardiac arrhythmias will not be included as subjects in this study.
• Medical condition that precludes participation, including the following:
• Hypertension with confirmed systolic blood pressure \>140 mmHg or confirmed diastolic blood pressure \>90 mmHg, measured after 10 - 15 minutes of rest.
• Morbid obesity (BMI\>35)
• Current diagnosis of pulmonary disease including latent TB
• Current diagnosis of asthma, which has required use of asthma medications within the past year
• History of or current diagnosis of diabetes
• Autoimmune disorder, such as lupus, Wegener's, rheumatoid arthritis
• History of malignancy except low-grade skin cancer, (i.e., basal cell carcinoma thought to be cured)
• Chronic renal, hepatic, or pulmonary disease condition that could interfere with the absorption of the study drug (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, irritable bowel syndrome, inflammatory bowel disease)
• History of known Clostridium difficile infection
• Blood donation within the previous 6 weeks
• History of cardiac rhythm abnormality including Wolff/Parkinson/White syndrome
• History of prolonged QT interval
• History of allergy or photosensitivity to fluoroquinolones

Sponsors & Collaborators

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

Study Sites (1)

Case Western Reserve University - Case Medical Center - Infectious Disease & HIV Medicine

Cleveland, Ohio, 44106-1716, United States

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: June 11, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 24, 2014

Record last verified: 2013-05

Locations

US (1)