HealthyPhase 1NCT02768519
Study to Evaluate Systemic Bioavailability of Oral OTS167 in Healthy Adult Subjects
A Phase 1 study testing OTS167IV and Cherry syrup in people with Healthy, run by OncoTherapy Science, Inc. at 1 site in Australia.
Trial summary
The purpose of this study is to determine the indicative bioavailability of a single oral dose of OTS167, and to evaluate the effects of food on OTS167 pharmacokinetics (PK) after oral dosing. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OTS167IV and Cherry syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2016to Feb 2016
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for participation in the study:
- Males or females aged 45 years or over.
- Female participants of non-childbearing potential, meeting at least one of the following criteria:
- Amenorrhoeal for 12 months (menopause confirmed by Follicular Stimulating Hormone (FSH) and Luteinising Hormone (LH) levels as defined by the established reference ranges), or
- Surgically sterile (e.g. hysterectomy, oophorectomy, tubal ligation) for at least the past 3 month.
- Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form (ICF).
- Able and willing to comply with the protocol, including availability for all scheduled study visits.
- Body mass index (BMI) 18 kg/m2 to 30 kg/m2 (inclusive)
- No clinically significant abnormalities as determined by medical history, physical examination, blood chemistry, hematology, urinalysis, and 12-lead electrocardiogram (ECGs).
- If male, agrees to use a medically acceptable method of contraception from Screening until 7 days after administration of the last dose of study drug. Medically acceptable methods of contraception include the following: abstinence; medically approved hormonal methods; condom; diaphragm; and intrauterine device. This requirement may be waived if the Principal Investigator or delegate is satisfied that the participant or partner is sterile (i.e., if female has undergone a hysterectomy, or has undergone a tubal ligation at least 3 months prior to Screening, or is postmenopausal [no menstrual period for at least 12 months prior to Screening]; if male, has undergone vasectomy at least 6 months prior to Screening). Male participants agree not to donate sperm for at least 90 days [3 months] after administration of the last dose of study drug.
- Agree to avoid drinking alcohol within 72 hours prior to check-in to the clinical facility.
- Adequate venous access in the left and right arm to allow collection of a number of blood samples.
Exclusion Criteria: Participants meeting any of the following criteria are ineligible for participation in the study.
- Evidence or history of clinical significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases
- Orthostatic blood pressure changes (>15mmHg) or symptoms, or presence of uncontrolled hypertension (SBP >160 mmHg or diastolic >95 mmHg) at screening, admission (Day -1) or pre-dose (Day 1).
- Greater than 2 standard drinks per day, on average, for men and women, or any history of drug or alcohol addiction or abuse within the last 5 years.
- History of allergic, anaphylaxis or hypersensitivity to OTS167 or excipients or contents of Humco ™ cherry syrup.
- Female participants who are currently lactating.
- Donated either blood or plasma (e.g., plasmapheresis) within 6 weeks prior to dosing in Period 1. All participants must be advised not to donate either blood or plasma for at least 6 weeks after completing the study.
- Use of prescription medications (with the exception of contraceptives), over-the-counter medications (with the exception of paracetamol [< 2 gm/day] or single-dose daily multivitamins), or herbal medications or products containing herbal extracts within 14 days prior to the first dose.
- Positive results on illicit drug test or alcohol breath test at screening or at admission.
- Positive screening test for HIV antibodies, Hepatitis B surface antigen or Hepatitis C antibody.
- Use of any investigational drug within the last 30 days or within a period of 5 times the drug's half-life, whichever is longer, or current participation in any investigational protocol.
- Participants who, in the opinion of the Principal Investigator or delegate, should not participate in the study or are not capable of following the study schedule for any reason.
- Either QTcF >450 or HR <40 or >100 at screening, admission (Day-1) or pre-dose (Day 1). Test may be repeated at discretion of investigator to obtain average in order to confirm eligibility.
Trial locations and contacts
1 site in 1 country.
Australia1 site
CMAX, Royal Adelaide Hospital
Adelaide, South Australia, 5000
About this study
Official title: A Phase 1, Randomised, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Systemic Bioavailability of Oral OTS167 Under Fed and Fasting Conditions in Healthy Adult Subjects
The purpose of this study is to determine the indicative bioavailability of a single oral dose of OTS167, and to evaluate the effects of food on OTS167 pharmacokinetics (PK) after oral dosing.
Eleven male and female healthy participants aged 45 years and over will be entered into this phase 1, single-centre, double-blind, randomised, cross-over study. The trial is designed to evaluate the bioavailability of OTS167, and the effects of food on pharmacokinetics (PK) of OTS167 when administered by the oral route. Correlative studies include evaluation of safety endpoints and examinations, and adverse events. This study involves 3 cohorts to evaluate the safety and tolerability of oral dosing from lower dose.
- Conditions
- Healthy
- Being tested
- OTS167IV, Cherry syrup
- Keywords
- Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTS167IVDrug
diluted to final concentration with cherry syrup
Cherry syrupOther
| Study group | Role | What they receive |
|---|---|---|
| OTS167IV | Experimental | Cohort 1: 0.5 mg, Cohort 2: 1.0 mg, and Cohort 3: 2.0 mg without food on Period 1 Day 1 and with food on Day 1 Period 2. Receives: Drug: OTS167IV |
| Placebo | Placebo comparator | Cherry syrup Receives: Other: Cherry syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Participants to be monitored throughout the treatment and follow-up period for occurrence of adverse events (AEs) (acute, delayed, and/or cumulative), as well as for changes in clinical status, vital signs, and laboratory data.
Safety assessments include concomitant medication survey, adverse events, temperature, pulse and respiratory rate, blood pressure, physical examination, hematologic parameters, serum chemistries, coagulation parameters, urinalyses, and 12-Lead ECG and cardiac telemetry.
Measured: 7 days after final study drug administration.
Maximum Plasma Concentration (Cmax)
Measured: 24 hours after final study drug administration.
Time of Maximum concentration (Tmax)
Measured: 24 hours after final study drug administration.
Area Under the Curve (AUC)
Measured: 24 hours after final study drug administration.
Half life (T1/2)
Measured: 24 hours after final study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoTherapy Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sepehr Shakib, Principal investigator, CMAX (A division of IDT Australia Ltd)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768519
- Sponsor's protocol ID
- OTS167-FR03
- Status last verified
- May 2017
- First submitted
- 13 Apr 2016
- Last updated
- 1 Jun 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Systemic Bioavailability of Oral OTS167 Under Fed and Fasting Conditions in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02768519
- Acronym / sponsor ID
- OTS167-FR03
- Conditions
- Healthy
- Keywords
- Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- OncoTherapy Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 May 2016 (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 purpose of this study is to determine the indicative bioavailability of a single oral dose of OTS167, and to evaluate the effects of food on OTS167 pharmacokinetics (PK) after oral dosing.
Eleven male and female healthy participants aged 45 years and over will be entered into this phase 1, single-centre, double-blind, randomised, cross-over study. The trial is designed to evaluate the bioavailability of OTS167, and the effects of food on pharmacokinetics (PK) of OTS167 when administered by the oral route. Correlative studies include evaluation of safety endpoints and examinations, and adverse events. This study involves 3 cohorts to evaluate the safety and tolerability of oral dosing from lower dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTS167IV | Experimental | Drug: OTS167IVCohort 1: 0.5 mg, Cohort 2: 1.0 mg, and Cohort 3: 2.0 mg without food on Period 1 Day 1 and with food on Day 1 Period 2. |
| Placebo | Placebo comparator | Other: Cherry syrupCherry syrup |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| OTS167IVdiluted to final concentration with cherry syrup | Drug | OTS167IV |
| Cherry syrup | Other | Placebo |
Primary outcome
Safety: Participants to be monitored throughout the treatment and follow-up period for occurrence of adverse events (AEs) (acute, delayed, and/or cumulative), as well as for changes in clinical status, vital signs, and laboratory data.
Time frame: 7 days after final study drug administration.
Safety assessments include concomitant medication survey, adverse events, temperature, pulse and respiratory rate, blood pressure, physical examination, hematologic parameters, serum chemistries, coagulation parameters, urinalyses, and 12-Lead ECG and cardiac telemetry.
Maximum Plasma Concentration (Cmax)
Time frame: 24 hours after final study drug administration.
Time of Maximum concentration (Tmax)
Time frame: 24 hours after final study drug administration.
Area Under the Curve (AUC)
Time frame: 24 hours after final study drug administration.
Half life (T1/2)
Time frame: 24 hours after final study drug 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 1 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Sepehr Shakib principal investigator
CMAX (A division of IDT Australia Ltd)
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 OTS167IV and Cherry syrup in people with Healthy, run by OncoTherapy Science, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Jun 2017. 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 Australia. 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 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: Participants to be monitored throughout the treatment and follow-up period for occurrence of adverse events (AEs) (acute, delayed, and/or cumulative), as well as for changes in clinical status, vital signs, and laboratory data. (time frame: 7 days after final study drug administration.). The study lists 5 primary outcomes in all. 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 1 Jun 2017.