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TuberculosisPhase 1NCT01874314

Effects of SQ109 on QTc Interval in Healthy Subjects

A Phase 1 study testing SQ109 and Moxifloxacin in people with Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Tuberculosis
What is being tested?
SQ109 and Moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Start not givento Dec 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Subjects meeting any exclusion criteria at baseline will be excluded from study partcipation.
  • 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
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  • 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
  • Prolongation of QTcF interval (i.e., confirmed QTcF interval of 450 milliseconds or greater)
  • Clinically significant abnormal 12 lead electrocardiogram at screening in the judgment of the investigator, or based on the formal ECG reading; history of any cardiac abnormalities, including conduction abnormalities such as Wolff-Parkinson-White, dysrhythmias, or coronary artery disease
  • Laboratory abnormalities at Screening outside of the ranges given below. Note, if one or more screening laboratory values are outside the acceptable range on the initial screen, the abnormal test(s) may be repeated once from a single blood draw:
  • Serum creatinine (<1.1 x ULN),
  • Hemoglobin (11.0-17.5g/dL),
  • Platelet count (125,000-450,000mm^3),
  • Absolute neutrophil count (>1300 mm^3),
  • Aspartate aminotransferase (AST, </=1.2 x ULN),
  • Alanine aminotransferase (ALT, </=1.2 x ULN),
  • Proteinuria greater than trace (spot urine) and/or hematuria greater than trace.
  • Positive serology results for HIV, HBsAg, or HCV antibodies
  • Positive urine drug screen for cannabinoids, cocaine, amphetamines, opiates, benzodiazepine, barbiturates, and/or PCP.
  • Febrile illness with temperature documented >38 degrees C within 7 days of dosing.
  • Pregnancy or breastfeeding
  • Known allergic reactions to study drug components, including ingredients present in the formulation.
  • Treatment with another investigational drug within 30 days of dosing.
  • Lack of ability to fully understand the informed consent. This will be determined by the recruiter/interviewer after explaining the consent and observing the subject reading the consent.
  • Ingestion of prescription medications, over-the-counter medicines, grapefruit juice, or specific supplements in the week prior to study enrollment and during the course of the study that, in the judgment of the PI could affect the metabolism of the study drug or safety of the participant (see Concomitant Medications, Section 6.6).
  • Use of any form of tobacco, including cigarette smoking, pipe smoking, or oral tobacco; if a former smoker or tobacco user, the subject must not have used tobacco for 30 days before screening.
  • Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Cleveland, Ohio, 44106-1716

Other trials in United States

About this study

Official title: Phase 1 Crossover Study to Assess the Effects of SQ109 on QTc Interval in Healthy Subjects

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

Read the detailed description

This is a Phase 1, randomized, single-center, clinical study of SQ109 to evaluate the potential for this drug to produce QTc prolongation. The study population is healthy male and female subjects, aged 18-45 years. Pharmacokinetics of SQ109 will be measured using interval plasma samples.The overall study design will incorporate within it a four-period investigation suitable for the QT evaluation of an active study treatment. The primary goal of the sample size considerations will be to ensure that the sample size employed during this phase of the study will be adequate to ensure a high likelihood of a successful demonstration of the QT safety of 300 and 450 mg/day SQ109. All subjects will be randomized to a sequence of three seven-day dosing periods, with each dosing period occurring once per subject. The final seven-day dosing period will occur after the first sequence of three dosing periods is completed. A washout period of at least seven days will occur between all dosing periods, and a follow-up visit will occur.

Conditions
Tuberculosis
Being tested
SQ109, SQ109 Placebo, Moxifloxacin
Keywords
tuberculosis, SQ109, QTc, moxifloxacin, crossover, placebo, pharmacokinetic, randomized, single-center
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SQ109Drug

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

  • SQ109 PlaceboOther

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

  • MoxifloxacinDrug

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

Study groups in NCT01874314
Study groupRoleWhat they receive
SQ109 450 mgExperimentalSingle daily dose of oral 450mg SQ109 for 7 days.
Receives: Drug: SQ109
MoxifloxacinActive comparatorSingle daily dose of oral 400mg moxifloxacin for 7 days followed by 7 days washout period.
Receives: Drug: Moxifloxacin
SQ109 PlaceboPlacebo comparatorSingle daily dose of oral SQ109 placebo for 7 days followed by 7 days washout period.
Receives: Other: SQ109 Placebo
SQ109 300 mgExperimentalSingle daily dose of oral 300mg SQ109 for 7 days followed by 7 days washout period.
Receives: Drug: SQ109

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

Secondary outcomes (3)

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

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

  2. 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

    Measured: Day 1 and Day 6 of each dosing period

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2013 (estimated)
  2. Primary completionDec 2015 (estimated)
  3. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01874314
Sponsor's protocol ID
11-0079
Other IDs
HHSN272200800026C
Status last verified
May 2013
First submitted
23 May 2013
Last updated
24 Mar 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SQ109 and Moxifloxacin in people with Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Solicited and unsolicited adverse events, including symptoms, physical findings, laboratory testing, holter monitor and ECG changes for 300mg/day SQ109 (time frame: Days 1-7 of each dosing period and 30 days after last dosing period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01874314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.

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