A First-in-Human Study of a new Controlled Release Formulation of Octreotide acetate in healthy male volunteers

Exclusion Criteria30

• Known thyroid disease, even if effectively euthyroid because of treatment.
• Known hypersensitivity to any component of the study drug;
• Planning for the female partner to become pregnant at any time during the study, including the follow-up period;
• Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator’s opinion, could adversely affect the safety of the participant;
• Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol;
• Background or clinical evidence of chronic diseases.
• Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the study drug, including impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract;
• Having undergone any major surgery during the 6 months prior to the first study drug administration;
• Blood donation or significant blood loss ( more or equal to 500mL within 60 days prior to the first study drug administration;
• Plasma donation within 7 days prior to the first study drug administration;
• Fever (body temperature more than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening;
• Any acute illness within 30 days prior to Day 0;
• History of severe allergic or anaphylactic reactions;
• Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
• History of malignancy except for non-melanoma skin cancer excised more than 2 years prior to Screening;
• Abnormal ECG findings at Screening including PR more or equal to 220 msec, QRS more ore equal to 120 msec, and Fridericia's correction more than 450 msec or ST wave changes or any other abnormal findings that are considered by the Investigator to be clinically significant,
• History or presence of a condition associated with significant immunosuppression;
• History of life-threatening infection (e.g. meningitis);
• Infections requiring parenteral antibiotics within the 1 month prior to Screening;
• Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical trial) within the 4 months prior to Screening or 5-half-lives, whichever is longer;
• Positive test for hepatitis C HCV virus antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening;
• Participants with a positive urine drug screen test (including: cotinine, amphetamines, methamphetamines, phencyclidine, barbiturate, methadone, tricyclic antidepressant, cocaine, opiates, cannabinoids and benzodiazepines), and alcohol breath test;
• Participants with a history of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 5 years (by self-declaration);
• Regular alcohol consumption defined as more than 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine). Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and during the confinement period;
• Regular consumption of stimulating beverages containing xantine defined as > 5 coffees, teas or coca cola drinks/ day, or more than 3 energy drinks/week. Participant is unwilling to abstain from stimulating beverages consumption beginning 48 hours prior to admission to the CRU and during the confinement period;
• Participants who used nicotine-based products (including smoking tobacco, smokeless tobacco, and nicotine patches) less than 6 months before informed consent.
• Use of any IP or investigational medical device within 90 days prior to Screening, or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to Screening;
• Use of any prescription drugs, over the counter (OTC) medication, herbal remedies, supplements or vitamins within 14 days prior to dosing and during course of study without prior approval of the Investigator and Medical Monitor. Simple analgesia (paracetamol) may be permitted at the discretion of the Investigator;
• Inability to refrain from consumption of grapefruit and Seville oranges or St. John’s Wort within 5 days prior to the first dose of study drug and until the final PK assessment;
• Participant is unwilling to refrain from strenuous exercise (including weight-lifting) from 3 days prior to admission to the CRU until completion of the final Follow-up visit.