Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule

NCT07312643 | Completed Phase 1 FDA Drug

• 1 other identifier: SOM230-RECAG-PK-0605
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center Phase 1 study in healthy male and female subjects of 18 to 55 years (inclusive) will follow an open-label, randomized, single-dose, crossover design with 2 intervention periods. The purpose of this study is to assess and compare the pharmacokinetic characteristics and the safety of single doses of pasireotide when administered subcutaneously by reusable ServoPen with cartridge or by syringe drawn from an ampule in healthy subjects.

Conditions

Pharmacokinetics; Safety

Keywords

pasireotide; subcutaneous; bioavailability

Outcome Measures

Primary Outcomes (3)

• AUC0-tlast

  To investigate the relative bioavailability (Frel) of pasireotide s.c. after single-dose administration of 2 dose levels using reusable ServoPen with cartridge (Test 1 and Test 2) compared to single-dose administration of 2 dose levels using syringe drawn from an ampule (Reference 1 and Reference 2).

  2 weeks

• AUC0-inf

  To investigate the relative bioavailability (Frel) of pasireotide s.c. after single-dose administration of 2 dose levels using reusable ServoPen with cartridge (Test 1 and Test 2) compared to single-dose administration of 2 dose levels using syringe drawn from an ampule (Reference 1 and Reference 2).

  2 weeks

• Cmax

  To investigate the relative bioavailability (Frel) of pasireotide s.c. after single-dose administration of 2 dose levels using reusable ServoPen with cartridge (Test 1 and Test 2) compared to single-dose administration of 2 dose levels using syringe drawn from an ampule (Reference 1 and Reference 2).

  2 weeks

Study Arms (4)

ServoPen 50 µg

EXPERIMENTAL

Single dose of 50 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge.

Combination Product: Pasireotide cartridge with reusable ServoPen

ServoPen 200 µg

EXPERIMENTAL

Single dose of 200 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge.

Combination Product: Pasireotide cartridge with reusable ServoPen

Syringe 50 µg

ACTIVE COMPARATOR

Single dose of 50 µg pasireotide administered subcutaneously using syringe drawn from an ampule.

Drug: Pasireotide ampule with syringe

Syringe 200 µg

ACTIVE COMPARATOR

Single dose of 200 µg pasireotide administered subcutaneously using syringe drawn from an ampule.

Drug: Pasireotide ampule with syringe

Interventions

Pasireotide ampule with syringe DRUG

Pasireotide ampule with syringe

Syringe 200 µg; Syringe 50 µg

Pasireotide cartridge with reusable ServoPen COMBINATION_PRODUCT

Pasireotide cartridge with reusable ServoPen

ServoPen 200 µg; ServoPen 50 µg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A subject is eligible only if all of the following criteria apply:
• Age of 18 to 55 years inclusive, at the time of signing the informed consent.
• BMI ≥18.5 kg/m2.
• Male or female. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• a. Male subjects: Male subjects are eligible to participate if they agree to the following starting from the first administration of study intervention until the follow-up visit:
• Refrain from donating semen. Plus, either:
• o Abstain from sexual intercourse with a partner of childbearing potential (definition in Section 10.5.1 of Study Protocol (SP)). OR
• o During sexual intercourse with a partner of childbearing potential, use a male condom and counsel the partner to use a highly effective contraceptive method (definitions in Section 10.5.2 of SP).
• b. Female subjects: A female subject is eligible to participate if she is neither pregnant nor breastfeeding, and one of the following conditions applies:
• Postmenopausal or has been sterilized more than 3 months ago (definitions in Section 10.5.1 of SP). OR
• Uses a highly effective (with a failure rate of \<1% per year) contraceptive method, preferably with low user dependency, as described in Section 10.5.2 during study participation and for at least 30 days after the last administration of study intervention and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
• ❑General Health Status
• Overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs and ECG.
• Clinically acceptable clinical laboratory test results.
• ❑Smoking

Sponsors & Collaborators

• RECORDATI GROUP: lead
• Nuvisan: collaborator

Study Sites (1)

Nuvisan GmBH

Neu-Ulm, 89231, Germany

Location

MeSH Terms

Interventions

Syringes

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 31, 2025
• Study Start: December 1, 2025
• Primary Completion: February 3, 2026
• Study Completion: February 3, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)