PharmacokineticsPhase 1PASIPHY_PENNCT07312643
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
A Phase 1 study testing Pasireotide cartridge with reusable ServoPen and Pasireotide ampule with syringe in people with Pharmacokinetics and Safety, run by RECORDATI GROUP at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Safety
- What is being tested?
- Pasireotide cartridge with reusable ServoPen and Pasireotide ampule with syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2025to 3 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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:
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- 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).
- 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
- Non-smoker, which includes abstinence from using other nicotine-containing products (e.g., nicotine patches, chewing gum, e-cigarettes) for at least the last 3 months prior to first administration of study intervention.
- Informed Consent
- Capable of giving signed informed consent as described in Section 10.1 of SP, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol prior to any clinical study-specific procedure.
- EXLCUSION:
- Subjects are excluded from the study if any of the following criteria apply:
- Medical Conditions
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- Any history or evidence of any clinically relevant and/or other major disease or malignancy as determined by medical evaluation (including physical examination) capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Contraindications for the use of pasireotide in medical history, such as ≥ moderate hepatic impairment (Child-Pugh B), hypocortisolism, uncontrolled diabetes, heart failure ≥ New York Heart Association Class III, cardiogenic shock, second- or third-degree AV block, sinoatrial block, sick sinus syndrome, severe bradycardia or congenital long QT syndrome.
- Medical history of pituitary disorder.
- History or presence of cholelithiasis and/or acute or chronic pancreatitis.
- Any clinically relevant history of allergic conditions requiring hospitalization or prolonged systemic treatment (including drug allergies, drug hypersensitivity, asthma, eczema, allergies requiring therapy with corticosteroids or anaphylactic reactions), excluding allergic contact sensitizations (e.g., nickel allergy). Subjects with uncomplicated seasonal allergic rhinitis can be accepted if the expected allergy season is clearly outside the study period.
- Known or suspected hypersensitivity to study interventions or any component of the formulations used.
- Clinically relevant chronic or acute infectious illness or febrile illness within the last 14 days prior to first administration of study intervention.
- Evidence of COVID-19 signs or symptoms or confirmed COVID-19 infection within the last 14 days prior to first administration of study intervention.
- Tendency for vasovagal reactions (e.g., after venipuncture) or history of syncope.
- Diagnostic Assessments
- Positive for hepatitis B surface antigen, hepatitis C antibody or anti-HIV 1 + 2 antibodies and HIV 1 p24 antigen.
- Positive test for alcohol or drugs of abuse.
- Positive pregnancy test in female subjects.
- Supine systolic blood pressure >140 mmHg or 90 mmHg or 90 bpm or tympanic body temperature 37.6°C.
- 12-lead ECG with clinically relevant abnormality or showing a QTcF>450 ms for male or >470 ms for female subjects, PR >215 ms or QRS >120 ms.
- Fasting glucose ≥ 5.5 mmol/L at screening and/or HbA1c > ULN at screening.
- ALT ≥1.5 x ULN, AST ≥1.5 x ULN or serum bilirubin ≥1.5 x ULN.
- eGFR calculated based on the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation
- Thyroid disorders as evidenced by TSH outside normal range and confirmed by free triiodothyronine and free thyroxine outside normal range. Subjects with suspected compensated thyroid hormone formation disorders as indicated by TSH outside normal range but free triiodothyronine and free thyroxine within normal range may be included at the discretion of the Investigator.
- Hypokalemia (potassium ≤ 3.5 mmol/L).
- Hypomagnesemia (magnesium < 0.7 mmol/L).
- ❑Prior/Concomitant Therapy
- Use of any concomitant medication or any drugs / medicines (including dietary supplements, natural and herbal remedies) within the last 14 days or 5 times their elimination half-life prior to first administration of study intervention, whichever is longer. Allowed treatments are the use of contraceptives as outlined in Section 10.5 of SP and HRT if the subject has been on stable treatment for at least 3 months and continues treatment throughout the study. Additionally, the occasional use of paracetamol (up to 2 g per day) and ibuprofen (up to 1.6 g per day) are allowed.
- ❑Prior/Concurrent Clinical Study Experience
- Use of any investigational drug or participation in any clinical study within 30 days or 5 times the half-life of the study drug administered in a previous study, whichever is longer, prior to the expected date of first administration of study intervention.
- Previous randomization in this study.
- ❑Other Exclusions
- Higher than low-risk alcohol consumption i.e., consumption of an average weekly alcohol intake of >14 units/week for men (daily dose of >24 g, weekly dose of >168 g) and >7 units/week for women (daily dose of >12 g, weekly dose of >84 g). One unit (12 g) corresponds to 0.3 L of beer/day or 0.12 L of wine/day or 2 cL of spirits/day.
- History of drug or alcohol abuse within the last 6 months.
- Excessive consumption of caffeine- or xanthine-containing food or beverages (>5 cups of coffee a day or equivalent) or inability to stop consuming within 48 h prior to planned administration of study intervention
- Intake of food, beverages, or other products containing grapefruit, grapefruit juice, grapefruit hybrids, star fruit, Seville orange, tangelo, pomelo, or exotic citrus fruits within 14 days prior to planned administration of study intervention.
- Consumption of poppy seed containing food within the last 72 h prior to the first administration of study intervention.
- Vegetarian, vegan, or restricted diet (e.g., gluten-free) or not willing or able to eat the standard meals provided.
- Donation or blood collection of more than 450 mL of blood or blood products or acute loss of blood within the last 30 days prior to the first administration of study intervention.
- Strenuous physical activity within the last 72 h prior to the first administration of study intervention.
- Employee of the Sponsor, the Nuvisan Group, or other CRO involved in the clinical study.
- Legal incapacity or limited legal capacity, or incarceration.
- Inability to understand or communicate reliably with the Investigator or considered by the Investigator to be unable to or unlikely to co-operate with the protocol requirements, instructions, and study-related restrictions.
- Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, Crossover 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
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.
Read the detailed description
Study details include:
- The study duration will be approximately 6.5 weeks per subject.
- Two (2) intervention periods are planned per dose level (50 µg and 200 µg), with 1 of the following interventions administered per period:
- Single dose of 50 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge.
- Single dose of 200 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge.
- Single dose of 50 µg pasireotide administered subcutaneously using syringe drawn from an ampule.
- Single dose of 200 µg pasireotide administered subcutaneously using syringe drawn from an ampule.
- The screening examination will be performed within 28 to 2 days prior to the first administration of study intervention.
- Subjects will stay in-house for at least 3 days per period.
- The ambulatory follow-up visit will be performed within 7 to 10 days after the last administration of study intervention.
- Conditions
- Pharmacokinetics, Safety
- Being tested
- Pasireotide cartridge with reusable ServoPen, Pasireotide ampule with syringe
- Keywords
- pasireotide, subcutaneous, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide cartridge with reusable ServoPenCombination product
Pasireotide cartridge with reusable ServoPen
Pasireotide ampule with syringeDrug
Pasireotide ampule with syringe
| Study group | Role | What they receive |
|---|---|---|
| ServoPen 50 µg | Experimental | Single dose of 50 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge. Receives: Combination Product: Pasireotide cartridge with reusable ServoPen |
| ServoPen 200 µg | Experimental | Single dose of 200 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge. Receives: 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. Receives: Drug: Pasireotide ampule with syringe |
| Syringe 200 µg | Active comparator | Single dose of 200 µg pasireotide administered subcutaneously using syringe drawn from an ampule. Receives: Drug: Pasireotide ampule with syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Dec 2025
- Primary completion3 Feb 2026
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nuvisan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312643
- Sponsor's protocol ID
- SOM230-RECAG-PK-0605
- Acronym
- PASIPHY_PEN
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Crossover 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
- ClinicalTrials.gov ID
- NCT07312643
- Acronym / sponsor ID
- PASIPHY_PEN / SOM230-RECAG-PK-0605
- Conditions
- Pharmacokinetics, Safety
- Keywords
- pasireotide, subcutaneous, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Collaborators
- Nuvisan
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study details include:
- The study duration will be approximately 6.5 weeks per subject.
- Two (2) intervention periods are planned per dose level (50 µg and 200 µg), with 1 of the following interventions administered per period:
- Single dose of 50 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge.
- Single dose of 200 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge.
- Single dose of 50 µg pasireotide administered subcutaneously using syringe drawn from an ampule.
- Single dose of 200 µg pasireotide administered subcutaneously using syringe drawn from an ampule.
- The screening examination will be performed within 28 to 2 days prior to the first administration of study intervention.
- Subjects will stay in-house for at least 3 days per period.
- The ambulatory follow-up visit will be performed within 7 to 10 days after the last administration of study intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ServoPen 50 µg | Experimental | Combination Product: Pasireotide cartridge with reusable ServoPenSingle dose of 50 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge. |
| ServoPen 200 µg | Experimental | Combination Product: Pasireotide cartridge with reusable ServoPenSingle dose of 200 µg pasireotide administered subcutaneously using reusable ServoPen with cartridge. |
| Syringe 50 µg | Active comparator | Drug: Pasireotide ampule with syringeSingle dose of 50 µg pasireotide administered subcutaneously using syringe drawn from an ampule. |
| Syringe 200 µg | Active comparator | Drug: Pasireotide ampule with syringeSingle dose of 200 µg pasireotide administered subcutaneously using syringe drawn from an ampule. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (61 listed)
- A subject is eligible only if all of the following criteria apply:
- 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).
- ❑General Health Status
- ❑Smoking
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasireotide cartridge with reusable ServoPenPasireotide cartridge with reusable ServoPen | Combination product | ServoPen 200 µg, ServoPen 50 µg |
| Pasireotide ampule with syringePasireotide ampule with syringe | Drug | Syringe 200 µg, Syringe 50 µg |
Primary outcome
AUC0-tlast
Time frame: 2 weeks
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).
AUC0-inf
Time frame: 2 weeks
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).
Cmax
Time frame: 2 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pasireotide cartridge with reusable ServoPen and Pasireotide ampule with syringe in people with Pharmacokinetics and Safety, run by RECORDATI GROUP at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 61 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-tlast (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.