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Trial registered on ANZCTR


Registration number
ACTRN12616000043437
Ethics application status
Approved
Date submitted
5/01/2016
Date registered
19/01/2016
Date last updated
23/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public 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.
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] 288234 0
Nil known
Universal Trial Number (UTN)
U1111-1178-0565
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 297159 0
Condition category
Condition code
Cancer 297378 297378 0 0
Leukaemia - Acute leukaemia
Cancer 297444 297444 0 0
Leukaemia - Chronic leukaemia
Cancer 297445 297445 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a single oral dose of OTS167 or placebo on the morning of Day 1. Participants in Cohorts 1 and 2 will receive a single oral dose following an overnight fast from food of at least 10 hours. Participants in Cohort 3 will receive two doses of OTS167 or placebo under both fed and fasting conditions, separated by a washout period of at least 4 days. For this study, fasting conditions means following an overnight fast from food of at least 10 hours. Fed conditions means study drug will be administered within 30 minutes of commencing a high fat, high calorie standard breakfast.
The doses evaluated in this study are listed below.
Cohort 1:0.5 mg or placebo
Cohort 2: 1 mg or placebo
Cohort 3: 2 mg or placebo

Study drug will be administered in cherry syrup to improve palatability.
Intervention code [1] 293523 0
Treatment: Drugs
Comparator / control treatment
Placebo: cherry syrup
Control group
Placebo

Outcomes
Primary outcome [1] 296932 0
To determine the indicative bioavailability of a single dose of OTS167 from analysis of blood samples collected following dose administration.
Timepoint [1] 296932 0
Blood samples will be collected on Day 1 at pre-dose then at 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 7 hours and 24 hours post each dose of study drug.
Primary outcome [2] 296933 0
To evaluate the effects of food on OTS167 pharmacokinetics (PK) after oral dosing from the assessment of Cmax, Tmax, AUC, t1/2 for OTS167.
Timepoint [2] 296933 0
Blood samples will be collected on Day 1 at pre-dose then at 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 7 hours and 24 hours post each dose of study drug.
Secondary outcome [1] 319725 0
Safety of OTS167 from adverse event documentation
Timepoint [1] 319725 0
Assessment of adverse events prior to the first dose of study drug and at Day 1, Day 2, Day 4, and 7 days following the last dose of study drug.

Eligibility
Key inclusion criteria
- Healthy males or females aged 45 years or over
- Females must be of non-child bearing potential
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases.
- Orthostatic blood pressure changes

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)
A randomisation code will be provided to the pharmacist by the CRO, which will be maintained in the pharmacy file. Study drug will be provided to site in a blinded fashion and site staff will be blinded as to the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation scheme will be generated by a statistician.
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
Other
Other design features
Cohorts 1 and 2 involve a single study treatment only. Cohort 3 will use a crossover design, with participants randomised to receive study drug under fed or fasting conditions in one of two sequences. Participants randomised to placebo will receive placebo in both periods. A washout period of at least 4 days will separate each period in Cohort 3. Study drug dose will be escalated with each subsequent cohort.
Phase
Phase 1
Type of endpoint(s)
Bio-availability
Statistical methods / analysis
Continuous variables, including baseline characteristics, will be summarised by reporting the number of observations, mean, standard deviation, median, minimum and maximum. Categorical/discrete variables will be summarised using frequency tables showing the number and percentage of participants within a particular category. Unless indicated otherwise, summary statistics will be reported for observed data only. Missing data will not be imputed. If a baseline value is missing, no change from baseline will be calculated. Baseline is defined as the last available observation prior to the first administration of study drug on Day 1 and Day 4.


The number of participants required to achieve the study objectives is not based on statistical considerations. The number of enrolled participants was agreed by the investigator and sponsor based on safety considerations.

Recruitment
Recruitment status
Completed
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 postcode(s) [1] 12484 0
5000 - Adelaide
Recruitment postcode(s) [2] 12485 0
5000 - Adelaide Bc

Funding & Sponsors
Funding source category [1] 292619 0
Commercial sector/Industry
Name [1] 292619 0
Oncotherapy Science, Inc.
Address [1] 292619 0
Kanagawa Science Park R&D D11F
3-2-1, Sakado, Takatsu-ku
Kawasaki City, Kanagawa pref.
213-0012
Japan
Country [1] 292619 0
Japan
Primary sponsor type
Commercial sector/Industry
Name
CMAX - a division of IDT Australia
Address
Level 5, East Wing
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 291337 0
None
Name [1] 291337 0
Address [1] 291337 0
Country [1] 291337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294097 0
Bellberry HREC
Ethics committee address [1] 294097 0
129 Glen Osmond Road,
Eastwood, SA 5063
Ethics committee country [1] 294097 0
Australia
Date submitted for ethics approval [1] 294097 0
25/11/2015
Approval date [1] 294097 0
04/01/2016
Ethics approval number [1] 294097 0
2015-11-779

Summary
Brief summary
The primary purpose of this study is to evaluate the absorption of the oral form of drug OTS167 in healthy volunteers, and to establish its safety.
Who is it for? You may be eligible to participate in this study if you are a healthy male or female volunteer aged 45 years or over.
Study details: All participants will be randomly allocated (by chance) to receive either the active drug, given in cherry syrup, or cherry syrup alone. This study will recruit participants in three stages. Those recruited to the first two stages will receive one dose on the morning of day 1 of either the active or inactive cherry syrup mixture after fasting for 10 hours (liquid will be permitted). Those recruited to the third stage will receive two separate doses of either the active or inactive cherry syrup mixture at least 4 days apart; once after fasting for 10 hours, and once in a fed state following a high fat, high calorie breakfast. All participants across all stages will have a number of blood samples taken over the 24 hours following each dose, and will be monitored for 4 days for side effects of the drug. It is hoped that the findings of this trial will provide further information on the absorption and distribution within the body of this oral formulation of OTS167, which may provide a more tolerable and convenient method of dosing for cancer patients.
Trial website
not applicable
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 62454 0
Dr Sepehr Shakib
Address 62454 0
c/o CMAX
Level 5, East Wing,
Royal Adelaide Hospital
North Terrace
SA 5000
Country 62454 0
Australia
Phone 62454 0
+61 8 8222 3923
Fax 62454 0
+61 8 8223 3475
Email 62454 0
sepehr.shakib@health.sa.gov.au
Contact person for public queries
Name 62455 0
Ms Christina Lekkas
Address 62455 0
c/o CMAX
Level 5, East Wing,
Royal Adelaide Hospital
North Terrace
SA 5000
Country 62455 0
Australia
Phone 62455 0
+61 8 8222 3923
Fax 62455 0
+61 8 8223 3475
Email 62455 0
christina.lekkas@cmax.com.au
Contact person for scientific queries
Name 62456 0
Dr Sepehr Shakib
Address 62456 0
c/o CMAX
Level 5, East Wing,
Royal Adelaide Hospital
North Terrace
SA 5000
Country 62456 0
Australia
Phone 62456 0
+61 8 8222 3923
Fax 62456 0
+61 8 8223 3475
Email 62456 0
sepehr.shakib@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary