A Phase 1, Open-Label, Randomized Study to Evaluate the Relative Bioavailability and Safety of Single-Dose Subcutaneous Pasireotide via Arm, Thigh, or Abdominal Administration in Healthy Subjects

The primary objective of this study is to evaluate the relative bioavailability of pasireotide following a single-dose subcutaneous administration in the arm or the thigh compared to the abdomen using a ServoPen. Assessment of these administration sites is clinically relevant to determine optimal delivery routes for subcutaneous medication. The study also aims to assess the safety of the drug in healthy subjects.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers of both male and female genders. The participants fall within age group 3. The clinical focus involves individuals with post-bariatric hypoglycemia.

This Phase 3 study is designed as a relative bioavailability and safety assessment to evaluate pasireotide following a single-dose subcutaneous administration in the arm, thigh, or abdomen using a ServoPen. The research methodology involves comparing the absorption characteristics of the drug across different injection sites in healthy subjects. The clinical sequence begins with a screening visit to determine eligibility, followed by the administration of the study drug and subsequent follow-up visits to monitor safety and pharmacokinetic parameters. The study concludes with an end-of-study visit. The total duration of participant involvement is determined by the scheduled monitoring periods required to assess the drug's profile. Early termination from the study may occur based on predefined safety criteria or protocol deviations.

The assessment of efficacy in this phase 3 clinical trial focuses on the management of post-bariatric hypoglycaemia. Specific parameters for evaluating therapeutic response and clinical outcomes are to be determined within the study protocol.