TB Multi-drug ResistantPhase 1NCT00866190
Dose Escalation Study of SQ109 in Healthy Adult Volunteers
A Phase 1 study testing SQ109 in people with TB Multi-drug Resistant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- TB Multi-drug Resistant
- What is being tested?
- SQ109
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Nov 2009
- 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
- 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):
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- 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.
- Subject agrees to comply with all study requirements, including clinic house rules.
Who cannot join
- 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.
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- 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.
- Subject has donated blood within the past 30 days prior to Day 1 of the study.
- Subject has allergy to ethambutol or related compounds.
- Subject is an employee of or family member of an employee of Sequella, Quintiles, or DynPort Vaccine Company LLC (DVC).
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase I Services
Overland Park, Kansas, 66211
About this study
Official title: A Phase 1B, Randomized, Placebo-Controlled, Double-Blinded, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single-Daily Doses of SQ109 in Normal, Healthy Male and Female Volunteers
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.
Read the detailed description
Tuberculosis (TB) is one of the most important global health problems. According to recent estimates from the World Health Organization, 8 million new cases of TB and 1.9 million deaths from TB occur annually, making TB the second leading cause of death from an infectious pathogen. Due to multidrug resistant TB, the need for new and more effective drugs to treat TB is well recognized. This study is a phase 1B, prospective, single-center, double-blinded, randomized, placebo-controlled, clinical study of SQ109 to evaluate single-daily dose tolerability and pharmacokinetics (PK) of oral SQ109 in healthy subjects. The objectives of the study are to: determine the safety and tolerability of SQ109 administered daily for 14 days in healthy male and female volunteers; assess single dose and multiple dose PK of SQ109 administered daily for 14 days in healthy male and female volunteers; and assess single dose and multiple dose PK of SQ109 administered twice per week after a 5-day loading regimen in healthy, male and female volunteers. A total of 30 subjects, ages 18-45, will be enrolled in the study, allocated equally among 3 cohorts of 10 subjects each, 8 treated with active drug and 2 with placebo. Subjects in Cohorts 1 and 3 will receive an oral dose of 75 mg or 150 mg, respectively, of study medication daily for 14 days. Subjects in Cohort 2 will receive 150 mg daily for 5 days followed by 2 additional doses of 150 mg on Days 9 and 14. Subject participation will include a screening visit within 28 days of study entry, a 14 day in-patient treatment period, and a 14 day out-patient follow-up phase. Safety will be assessed by study personnel continually during the 14 day in-patient treatment period and the out-patient follow-up phase. Adverse events will be recorded for all subjects. Other safety measures include laboratory tests, electrocardiograms (ECGs), visual and neurological assessments, physical examinations, and vital signs. Study duration will be approximately 6 months. Subject participation duration will be 56 days.
- Conditions
- TB Multi-drug Resistant
- Being tested
- SQ109, Placebo
- Keywords
- Mycobacterium tuberculosis, SQ109
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQ109Drug
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.
PlaceboDrug
Placebo is an oval, coated, white, scored tablet administered once daily for 14 days or on Days 1-5, 9, and 14.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | SQ109 dose 75 mg or placebo once daily for 14 days. Receives: Drug: SQ109; Drug: Placebo |
| Cohort 3 | Experimental | SQ109 dose 150 mg or placebo once daily for 14 days. Receives: Drug: SQ109; Drug: Placebo |
| Cohort 2 | Experimental | SQ109 dose 150 mg or placebo once daily on Days 1-5, 9, and 14. Receives: Drug: SQ109; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TB Multi-drug ResistantStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866190
- Sponsor's protocol ID
- 08-0048
- Other IDs
- N01AI80024C, SQ-109
- Status last verified
- Oct 2009
- First submitted
- 19 Mar 2009
- Last updated
- 7 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Randomized, Placebo-Controlled, Double-Blinded, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single-Daily Doses of SQ109 in Normal, Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT00866190
- Acronym / sponsor ID
- 08-0048
- Conditions
- TB Multi-drug Resistant
- Keywords
- Mycobacterium tuberculosis, SQ109
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tuberculosis (TB) is one of the most important global health problems. According to recent estimates from the World Health Organization, 8 million new cases of TB and 1.9 million deaths from TB occur annually, making TB the second leading cause of death from an infectious pathogen. Due to multidrug resistant TB, the need for new and more effective drugs to treat TB is well recognized. This study is a phase 1B, prospective, single-center, double-blinded, randomized, placebo-controlled, clinical study of SQ109 to evaluate single-daily dose tolerability and pharmacokinetics (PK) of oral SQ109 in healthy subjects. The objectives of the study are to: determine the safety and tolerability of SQ109 administered daily for 14 days in healthy male and female volunteers; assess single dose and multiple dose PK of SQ109 administered daily for 14 days in healthy male and female volunteers; and assess single dose and multiple dose PK of SQ109 administered twice per week after a 5-day loading regimen in healthy, male and female volunteers. A total of 30 subjects, ages 18-45, will be enrolled in the study, allocated equally among 3 cohorts of 10 subjects each, 8 treated with active drug and 2 with placebo. Subjects in Cohorts 1 and 3 will receive an oral dose of 75 mg or 150 mg, respectively, of study medication daily for 14 days. Subjects in Cohort 2 will receive 150 mg daily for 5 days followed by 2 additional doses of 150 mg on Days 9 and 14. Subject participation will include a screening visit within 28 days of study entry, a 14 day in-patient treatment period, and a 14 day out-patient follow-up phase. Safety will be assessed by study personnel continually during the 14 day in-patient treatment period and the out-patient follow-up phase. Adverse events will be recorded for all subjects. Other safety measures include laboratory tests, electrocardiograms (ECGs), visual and neurological assessments, physical examinations, and vital signs. Study duration will be approximately 6 months. Subject participation duration will be 56 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SQ109, Drug: PlaceboSQ109 dose 75 mg or placebo once daily for 14 days. |
| Cohort 3 | Experimental | Drug: SQ109, Drug: PlaceboSQ109 dose 150 mg or placebo once daily for 14 days. |
| Cohort 2 | Experimental | Drug: SQ109, Drug: PlaceboSQ109 dose 150 mg or placebo once daily on Days 1-5, 9, and 14. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQ109SQ109 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. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboPlacebo is an oval, coated, white, scored tablet administered once daily for 14 days or on Days 1-5, 9, and 14. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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.
Time frame: Duration of study.
1 secondary outcome
Serial blood samples for the measurement of the plasma levels of SQ109 will be collected. Pharmacokinetic variables will be assessed.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SQ109 in people with TB Multi-drug Resistant, 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 16 inclusion and 18 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: finished, as of the sponsor's last update on 7 Nov 2011. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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. (time frame: Duration of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2011; AzTrials last refreshed its copy on 8 Nov 2026.