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

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.