The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02768519




Registration number
NCT02768519
Ethics application status
Date submitted
13/04/2016
Date registered
11/05/2016
Date last updated
1/06/2017

Titles & IDs
Public title
Study to Evaluate Systemic Bioavailability of Oral OTS167 in Healthy Adult Subjects
Scientific 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
Secondary ID [1] 0 0
OTS167-FR03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OTS167IV
Other interventions - Cherry syrup

Experimental: OTS167IV - 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.

Placebo Comparator: Placebo - Cherry syrup


Treatment: Drugs: OTS167IV
diluted to final concentration with cherry syrup

Other interventions: Cherry syrup


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
7 days after final study drug administration.
Primary outcome [2] 0 0
Maximum Plasma Concentration (Cmax)
Timepoint [2] 0 0
24 hours after final study drug administration.
Primary outcome [3] 0 0
Time of Maximum concentration (Tmax)
Timepoint [3] 0 0
24 hours after final study drug administration.
Primary outcome [4] 0 0
Area Under the Curve (AUC)
Timepoint [4] 0 0
24 hours after final study drug administration.
Primary outcome [5] 0 0
Half life (T1/2)
Timepoint [5] 0 0
24 hours after final study drug administration.

Eligibility
Key inclusion criteria
Participants must meet all of the following criteria to be eligible for
participation in the study:

1. Males or females aged 45 years or over.

2. 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.

3. Able to communicate with site personnel and to understand and voluntarily sign the
Informed Consent Form (ICF).

4. Able and willing to comply with the protocol, including availability for all scheduled
study visits.

5. Body mass index (BMI) 18 kg/m2 to 30 kg/m2 (inclusive)

6. No clinically significant abnormalities as determined by medical history, physical
examination, blood chemistry, hematology, urinalysis, and 12-lead electrocardiogram
(ECGs).

7. 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.

8. Agree to avoid drinking alcohol within 72 hours prior to check-in to the clinical
facility.

9. Adequate venous access in the left and right arm to allow collection of a number of
blood samples.
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants meeting any of the following criteria are ineligible for
participation in the study.

1. Evidence or history of clinical significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic diseases

2. 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).

3. 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.

4. History of allergic, anaphylaxis or hypersensitivity to OTS167 or excipients or
contents of Humco ™ cherry syrup.

5. Female participants who are currently lactating.

6. 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.

7. 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.

8. Positive results on illicit drug test or alcohol breath test at screening or at
admission.

9. Positive screening test for HIV antibodies, Hepatitis B surface antigen or Hepatitis C
antibody.

10. 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.

11. 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.

12. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OncoTherapy Science, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.

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.
Trial website
https://clinicaltrials.gov/show/NCT02768519
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sepehr Shakib
Address 0 0
CMAX (A division of IDT Australia Ltd)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications