A First-in-Human Study of a new Controlled Release Formulation of Octreotide acetate in healthy male volunteers
- Conditions
- AcromegalyNeuroendocrine TumoursMetabolic and Endocrine - Other endocrine disordersCancer - Neuroendocrine tumour (NET)
- Registration Number
- ACTRN12620000108910
- Lead Sponsor
- Ascil Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 8
1.Healthy male subjects, aged 18-45 years (inclusive at the time of informed consent);
2.Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and before administration of the initial dose of study drug;
3.Participants must have a minimum body weight of 50kg, and the BMI index (expressed as weight [kg] / height [m2]) must be between 19 and 29 at Screening.
4.Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator;
5.Participants must have no relevant dietary restrictions, and be willing to consume standard meals provided during the confinement period;
6.Participants engaged in sexual relations with a woman of childbearing potential (WOCBP) must use an acceptable, highly effective, double-barrier contraceptive method from Screening until at least 90 days after dosing. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner that include: oral contraceptive pills (OCPs), long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device (IUD). Participants with same sex partners (abstinence from penile-vaginal intercourse), participants who are surgically sterile (>30 days since vasectomy with no viable sperm), participants whose female partner is post-menopausal or abstinent participants are eligible when this is their preferred and usual lifestyle;
7.Participants must not donate sperm for at least 90 days after dosing with the study drug;
8.Participants must have the ability and willingness to attend the necessary visits to the Clinical Research Unit (CRU);
9.Clinically acceptable blood pressure and pulse rate in supine (systolic blood pressure -SBP- between 90-140 mm Hg/ diastolic blood pressure -DBP- between 50-95 mm Hg / heart rate -HR- between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 10 minutes of resting.
10.Able to understand the nature of the study and comply with all their requirements.
11.Participants must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
1.Known thyroid disease, even if effectively euthyroid because of treatment.
2.Known hypersensitivity to any component of the study drug;
3.Planning for the female partner to become pregnant at any time during the study, including the follow-up period;
4.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;
5.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;
6.Background or clinical evidence of chronic diseases.
7.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;
8.Having undergone any major surgery during the 6 months prior to the first study drug administration;
9.Blood donation or significant blood loss ( more or equal to 500mL within 60 days prior to the first study drug administration;
10.Plasma donation within 7 days prior to the first study drug administration;
11.Fever (body temperature more than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening;
12.Any acute illness within 30 days prior to Day 0;
13.History of severe allergic or anaphylactic reactions;
14.Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
15.History of malignancy except for non-melanoma skin cancer excised more than 2 years prior to Screening;
16.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,
17.History or presence of a condition associated with significant immunosuppression;
18.History of life-threatening infection (e.g. meningitis);
19.Infections requiring parenteral antibiotics within the 1 month prior to Screening;
20.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;
21.Positive test for hepatitis C HCV virus antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening;
22.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;
23.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);
24.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;
25.Regular consumption of stimulat
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method