Relative Bioavailability and Food Effect Study of IX-01 Capsules in Healthy Men
Condition: Healthy Participants
Intervention: IX-01
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the absorption and blood levels of IX-01 when given
      as a capsule compared to liquid form, and how food affects the absorption in healthy men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A body mass index (Quetelet index) in the range 18-30 kilograms/meters squared (kg/m2)

          -  Body Mass Index = weight [kg] divided by (height [m])2

          -  Total body weight greater than (>)50 kg at screening

          -  Ability to communicate satisfactorily with the investigator and to participate in, and
             comply with the requirements of, the entire trial

          -  Participants and their partners must be willing to use adequate forms of contraception
             and to comply with the contraception requirements during the trial and for 4 months
             after the last dose of medication

          -  Willingness to give written consent to have data entered into The Over Volunteering
             Prevention System

        Exclusion Criteria:

          -  Clinically relevant abnormal history, physical findings, ECG, or laboratory values at
             the pre-trial screening assessment, including:

               -  Lipid and/or liver function test results >1.25 x Upper Limit of Normal (ULN) or
                  other clinical laboratory blood biochemistry test results outside the normal
                  reference range unless discussed and approved by sponsor

               -  International normalised ratio (INR) of >1.2 or a platelet count < 150 x
                  109/Liter

               -  History of unexplained syncope

               -  Family history of unexplained sudden death, or sudden death due to long QT
                  syndrome

               -  Fridericia Correction Formula (QTcF) interval >450 milliseconds (msec) at
                  screening

               -  Bundle branch block and other conduction abnormalities, other than mild first
                  degree atrio-ventricular block

               -  Irregular rhythms other than sinus arrhythmia or occasional supraventricular
                  ectopic beats

               -  T-wave configuration of insufficient quality for determination of QT interval, as
                  assessed by the investigator

          -  Presence of acute or chronic illness or history of chronic illness sufficient to
             invalidate participation in the trial

          -  Impaired gastrointestinal, endocrine, thyroid, hepatic, cardiovascular, respiratory,
             haematological, renal or neurological function, diabetes mellitus, coronary heart
             disease, or history of any psychotic mental illness

          -  Surgery (for example (e.g.) stomach bypass) or medical condition that might affect
             absorption, metabolism or elimination of medicines

          -  Any skin condition, abnormality of the lumbar spine, medical or surgical condition
             that would preclude lumbar puncture (e.g. coagulopathy, local or systemic infection,
             left ventricular outflow obstruction, aortic stenosis, previous back surgery)

          -  Presence or history of severe adverse reaction to any drug

          -  Use of any prescription or over-the-counter medicine during the 14 days before the
             first dose of trial medication, or intention to use any medicine during the trial,
             with the exception of short courses of medication considered by the investigator not
             to interfere with the safety of the participant or the integrity of the trial data
             (such as acetaminophen (paracetamol))

          -  Current use of any herbal remedy or nutritional supplement, or intention to use any
             such product during the study

          -  Participation in another clinical trial of a new chemical entity or a prescription
             medicine within the previous 3 months.

          -  Previous participation in this trial or any other clinical trial of an oxytocin
             receptor antagonist

          -  Presence or history of drug or alcohol abuse, or intake of more than 21 units of
             alcohol weekly or more than 5 cigarettes daily

          -  Blood pressure and heart rate in supine position at the screening examination outside
             the ranges 100-130 millimeters of mercury (mm Hg) systolic, 60-90 mm Hg diastolic;
             heart rate 50-100 beats/minute. Measurements must be made in duplicate, and all values
             must fall within the acceptable ranges

          -  Possibility that the participant will not cooperate with the requirements of the
             protocol

          -  Evidence of drug abuse on urine testing

          -  Positive test for hepatitis B, hepatitis C, Human Immunodeficiency Virus 1 (HIV1) or
             Human Immunodeficiency Virus 2 (HIV2)

          -  Loss of more than 400 mL blood during the 3 months before the trial, e.g. as a blood
             donor

          -  Objection by General Practitioner (GP), on medical grounds, to participant entering
             trial

          -  Employee of the investigator site or any company involved in sponsoring, organizing or
             conducting the trial, or immediate family of the employee