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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.
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Inclusion and exclusion criteria
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:
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.
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11 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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