TuberculosisPhase 1NCT01585636
Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers
A Phase 1 study testing SQ109 in people with Tuberculosis, run by Sequella, Inc. at 1 site in United States.
Trial summary
This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis. If single doses are safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy volunteers and patients with pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- SQ109
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2007
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be 18 to 55 years of age.
- Subject must be a healthy male or female volunteer (i.e., hematology, coagulation,clinical chemistries and urinalysis tests must be within normal, allowable limits).
- Clinical laboratory tests must be performed within 21 days of receiving first dose of study drug.
- Body weight must be ± 20% of the ideal for height and estimated frame based on the 1983 Metropolitan Life Insurance Company table.
- Subject must give voluntary written informed consent before any study related procedure is performed.
- Female subjects will be postmenopausal, surgically sterile, or agree to use two forms of contraception from screening through 30 days after the dose of study drug. All female subjects of childbearing potential must have a negative urine pregnancy test at screening.
- Male subjects must agree to use an acceptable barrier method for birth control from screening through 30 days after the dose of study drug.
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 Investigator, 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 donated blood within 30 days or plasma within 14 days of study dosing.
- Subject has participated in any clinical trial within 30 days prior to study initiation; herein, 30 days are defined as 30 days from the last dosing in a clinical trial
- Subject has used any over-the-counter (OTC) medication, including vitamins, within 7 days prior to the study.
- Subject has used any prescription medication within 14 days prior to the study.
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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 the study.
- Subject has a positive blood screen for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody and/or a positive urine screen for alcohol or drugs of abuse.
- Subject has smoked or used tobacco products within 2 months prior to or during the study.
- Subject has an uncontrolled intercurrent illness (i.e., active infection).
- Subject has had major surgery within 4 weeks of study entry.
- Subject has another serious medical or psychiatric illness that could, in the Investigator's opinion, interfere with the completion of treatment according to this protocol.
- Subjects who are color-blind.
- Subjects with QTc interval prolongation (> 450 msec) or a history of QTc interval prolongation.
- Subjects with a history of alcohol abuse, drug and/or food allergies.
- Subjects who intend to consume grapefruit juice during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phaes 1 Clinical Study Unit
Lenexa, Kansas, 66219
About this study
Official title: A Phase Ia, Randomized, Placebo-Controlled, Single-Dose, Double-Blind, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of SQ109 in Normal, Healthy Male and Female Volunteers
This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis. If single doses are safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy volunteers and patients with pulmonary tuberculosis.
- Conditions
- Tuberculosis
- Being tested
- SQ109
- Keywords
- SQ109, Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQ109Drug
Single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 5 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo Receives: Drug: SQ109 |
| 10 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo Receives: Drug: SQ109 |
| 20 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo Receives: Drug: SQ109 |
| 50 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo Receives: Drug: SQ109 |
| 100 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo Receives: Drug: SQ109 |
| 200 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo Receives: Drug: SQ109 |
| 300 mg dose group | Experimental | 8 subjects: 6 received active drug, 2 received matching placebo Receives: Drug: SQ109 |
| Food effect group | Experimental | 6 Subjects received single, 300 mg SQ109 after high-fat, high-calorie meal. Receives: Drug: SQ109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Compared to baseline measurements:
Change in Hb, Hct, WBC count / differential, platelet count Change in serum chemistry parameters Change in visual acuity Alteration in color perception Changes in cranial, sensory or motor nerve function, and mental status (as defined by the mini mental status examination) Prolongation in QTc interval, and rhythm changes by electrocardiogram
Measured: daily examinations for 7 days after single dose drug administration
Secondary outcomes (1)
Pharmacokinetics of SQ109 in fasted subjects and effect of high-fat, high calorie meal on pharmacokinetics
maximum serum concentration (Cmax) Time to Cmax (Tmax) Area under the curve (AUC) Volume of Distribution (Vz/F) Oral clearance (CL/F)
Measured: pK samples collected for 96 hours post dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startSep 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequella, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585636
- Sponsor's protocol ID
- SQ109-CP001
- Status last verified
- Aug 2013
- First submitted
- 20 Apr 2012
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Randomized, Placebo-Controlled, Single-Dose, Double-Blind, Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of SQ109 in Normal, Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT01585636
- Acronym / sponsor ID
- SQ109-CP001
- Conditions
- Tuberculosis
- Keywords
- SQ109, Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sequella, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Sep 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 26 Apr 2012 (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.
This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis. If single doses are safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy volunteers and patients with pulmonary tuberculosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 5 mg dose group | Experimental | Drug: SQ1098 subjects: 6 received active drug, 2 received matching placebo |
| 10 mg dose group | Experimental | Drug: SQ1098 subjects: 6 received active drug, 2 received matching placebo |
| 20 mg dose group | Experimental | Drug: SQ1098 subjects: 6 received active drug, 2 received matching placebo |
| 50 mg dose group | Experimental | Drug: SQ1098 subjects: 6 received active drug, 2 received matching placebo |
| 100 mg dose group | Experimental | Drug: SQ1098 subjects: 6 received active drug, 2 received matching placebo |
| 200 mg dose group | Experimental | Drug: SQ1098 subjects: 6 received active drug, 2 received matching placebo |
| 300 mg dose group | Experimental | Drug: SQ1098 subjects: 6 received active drug, 2 received matching placebo |
| Food effect group | Experimental | Drug: SQ1096 Subjects received single, 300 mg SQ109 after high-fat, high-calorie meal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject must be 18 to 55 years of age.
- Subject must be a healthy male or female volunteer (i.e., hematology, coagulation,clinical chemistries and urinalysis tests must be within normal, allowable limits).
- Clinical laboratory tests must be performed within 21 days of receiving first dose of study drug.
- Body weight must be ± 20% of the ideal for height and estimated frame based on the 1983 Metropolitan Life Insurance Company table.
- Subject must give voluntary written informed consent before any study related procedure is performed.
Key exclusion criteria (16 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 Investigator, 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 donated blood within 30 days or plasma within 14 days of study dosing.
- Subject has participated in any clinical trial within 30 days prior to study initiation; herein, 30 days are defined as 30 days from the last dosing in a clinical trial
- Subject has used any over-the-counter (OTC) medication, including vitamins, within 7 days prior to 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 |
|---|---|---|
| SQ109Single oral dose | Drug | 10 mg dose group, 100 mg dose group, 20 mg dose group, 200 mg dose group, 300 mg dose group, 5 mg dose group, 50 mg dose group, Food effect group |
Primary outcome
Safety
Time frame: daily examinations for 7 days after single dose drug administration
Compared to baseline measurements: Change in Hb, Hct, WBC count / differential, platelet count Change in serum chemistry parameters Change in visual acuity Alteration in color perception Changes in cranial, sensory or motor nerve function, and mental status (as defined by the mini mental status examination) Prolongation in QTc interval, and rhythm changes by electrocardiogram
1 secondary outcome
Pharmacokinetics of SQ109 in fasted subjects and effect of high-fat, high calorie meal on pharmacokinetics
Time frame: pK samples collected for 96 hours post dose administration
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 19 Aug 2013.
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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 Tuberculosis, run by Sequella, Inc. 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 7 inclusion and 16 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 19 Aug 2013. 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 (time frame: daily examinations for 7 days after single dose drug administration). 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 19 Aug 2013.