A Phase I Study to evaluate the Pharmacokinetics and the Safety of a Controlled Release Formulation of Lanreotide acetate in Healthy Male Volunteers

Ascil Australia Pty LTD0 sites16 target enrollmentNovember 24, 2020

ConditionsAcromegaly Neuroendocrine Tumours Metabolic and Endocrine - Other endocrine disorders Cancer - Neuroendocrine tumour (NET)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acromegaly
Sponsor: Ascil Australia Pty LTD
Enrollment: 16
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 24, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Ascil Australia Pty LTD

Eligibility Criteria

Inclusion Criteria

•1\. Healthy male subjects, aged 18\-50 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 (inclusive) 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, as per their normal dietary requirements;
•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 (greater than 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.

Exclusion Criteria

•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 followup 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;