Study to Evaluate Systemic Bioavailability of Oral OTS167 in Healthy Adult Subjects

May 31, 2017 updated by: OncoTherapy Science, Inc.

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • CMAX, Royal Adelaide Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
diluted to final concentration with cherry syrup
PLACEBO_COMPARATOR: Placebo
Cherry syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days after final study drug administration.
Maximum Plasma Concentration (Cmax)
Time Frame: 24 hours after final study drug administration.
24 hours after final study drug administration.
Time of Maximum concentration (Tmax)
Time Frame: 24 hours after final study drug administration.
24 hours after final study drug administration.
Area Under the Curve (AUC)
Time Frame: 24 hours after final study drug administration.
24 hours after final study drug administration.
Half life (T1/2)
Time Frame: 24 hours after final study drug administration.
24 hours after final study drug administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sepehr Shakib, CMAX (A Division of IDT Australia Ltd)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (ESTIMATE)

May 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OTS167-FR03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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