Healthy SubjectsPhase 1NCT03279302
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
A Phase 1 study testing Glepaglutide in people with Healthy Subjects, run by Zealand Pharma at 1 site in United States.
Trial summary
The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Glepaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2017to 18 Dec 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
- Body Mass index between 18 and 30.0 kg/m2
- Able to comply with all the trial procedures
- females will not be pregnant or lactating
- If female of childbearing potential or male agree to use contraception as defined in the protocol
- Male subjects must also be willing to refrain from donating sperm from trial Check-in until 90 days after the last dose
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of bowel obstruction, stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and/or cholecystectomy or hernia repair will be allowed).
- Clinically significant abnormality on 12-lead ECG
- Clinically significant abnormality in hematology, clinical chemistry, or urinalysis
- History of alcoholism or drug/chemical abuse within 2 years
Show all 16Show fewer
- Alcohol consumption of > 21 units per week for males and > 14 units for females
- Positive urine drug screen
- Positive hepatitis panel and/or positive human immunodeficiency test
- Receipt of any investigational product within 30 days or 5 half-lives
- Previous exposure to GLP-1, GLP-2, human growth hormone, or analogs thereof 30 days prior to Check-in
- Use or intend to use any medications/products known to be strong inhibitors or strong inducers of cytochrome P450 3A enzyme, including St. John's wort
- Use of tobacco, smoking cessation products, or products containing nicotine (including but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine lozenges, or nicotine gum ) within 3 months prior to Screening
- Receipt of blood products within 2 months prior to Check-in and throughout the trial.
- Donation of blood or significant blood loss from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening and throughout the trial.
- Poor peripheral venous access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Partially Randomized, 3-Part, Parallel Group Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide (ZP1848) After a Single Intravenous Injection and After Multiple Subcutaneous Injections in Healthy Subjects
The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects.
Glepaglutide is a proposed International Nonproprietary Name for ZP1848
- Conditions
- Healthy Subjects
- Being tested
- Glepaglutide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlepaglutideDrug
Also called ZP1848
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 1 mg glepaglutide once daily, given as single SC injections on Days 1 to 7 Receives: Drug: Glepaglutide |
| Group B | Experimental | 5 mg glepaglutide once daily, given as single SC injections on Days 1 to 7 Receives: Drug: Glepaglutide |
| Group C | Experimental | 5 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36 Receives: Drug: Glepaglutide |
| Group D | Experimental | 10 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36 Receives: Drug: Glepaglutide |
| Group E | Experimental | 1 mg glepaglutide, given as an IV infusion at a rate of 4 mg/h for 15 minutes on Day 1 Receives: Drug: Glepaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter - half life
Half life of glepaglutide and active metabolites
Measured: Day 0 up to Day 73
Pharmacokinetic parameter - total body clearance
Total body clearance after IV administration
Measured: Day 0 to Day 22
Pharmacokinetic parameter - Apparent clearance
CL/F for subcutaneous doses
Measured: Day 0 to Day 73
Pharmacokinetic parameter - Volume of distribution
Volume of distribution after IV dosing
Measured: Day 0- Day 22
Pharmacokinetic parameter - apparent volume of distribution
Vss/F and Vz/F for subcutaneous doses
Measured: Day 0 to Day 73
Secondary outcomes (7)
Pharmacokinetic parameter - Cmax
Maximum observed plasma concentration
Measured: Day 0 to Day 73
Pharmacokinetic parameter - tmax
time of maximum observed plasma concentration
Measured: Day 0 to Day 73
Pharmacokinetic parameter - AUC
Area under the curve
Measured: Day 0 to Day 73
Pharmacodynamic parameter - plasma citrulline levels
change in plasma citrulline levels
Measured: Day 0 to Day 73
ADA incidence
Overall incidence of anti-glepaglutide antibodies
Measured: Day 0 to Day 73
Safety and tolerability - AEs
Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions
Measured: Day 0 to Day 73
Safety and tolerability - ECGs
12 lead electrocardiogram parameters
Measured: Day 0 to Day 73
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start4 Sep 2017
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279302
- Sponsor's protocol ID
- ZP1848-16182
- Status last verified
- Dec 2017
- First submitted
- 5 Sep 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Agersnap MA, Sonne K, Knudsen KM, Knudsen CB, Berner-Hansen M. Pharmacokinetics of Glepaglutide, A Long-Acting Glucagon-Like Peptide-2 Analogue: A Study in Healthy Subjects. Clin Drug Investig. 2022 Dec;42(12):1093-1100. doi: 10.1007/s40261-022-01210-1. Epub 2022 Nov 2.
PubMed 36323988
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Partially Randomized, 3-Part, Parallel Group Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide (ZP1848) After a Single Intravenous Injection and After Multiple Subcutaneous Injections in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03279302
- Acronym / sponsor ID
- ZP1848-16182
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 12 Sep 2017 (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.
The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects.
Glepaglutide is a proposed International Nonproprietary Name for ZP1848
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Glepaglutide1 mg glepaglutide once daily, given as single SC injections on Days 1 to 7 |
| Group B | Experimental | Drug: Glepaglutide5 mg glepaglutide once daily, given as single SC injections on Days 1 to 7 |
| Group C | Experimental | Drug: Glepaglutide5 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36 |
| Group D | Experimental | Drug: Glepaglutide10 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36 |
| Group E | Experimental | Drug: Glepaglutide1 mg glepaglutide, given as an IV infusion at a rate of 4 mg/h for 15 minutes on Day 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
- Body Mass index between 18 and 30.0 kg/m2
- Able to comply with all the trial procedures
- females will not be pregnant or lactating
- If female of childbearing potential or male agree to use contraception as defined in the protocol
Key exclusion criteria (16 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of bowel obstruction, stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and/or cholecystectomy or hernia repair will be allowed).
- Clinically significant abnormality on 12-lead ECG
- Clinically significant abnormality in hematology, clinical chemistry, or urinalysis
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 |
|---|---|---|
| GlepaglutideAlso: ZP1848Solution for injection | Drug | Group A, Group B, Group C, Group D, Group E |
Primary outcome
Pharmacokinetic parameter - half life
Time frame: Day 0 up to Day 73
Half life of glepaglutide and active metabolites
Pharmacokinetic parameter - total body clearance
Time frame: Day 0 to Day 22
Total body clearance after IV administration
Pharmacokinetic parameter - Apparent clearance
Time frame: Day 0 to Day 73
CL/F for subcutaneous doses
Pharmacokinetic parameter - Volume of distribution
Time frame: Day 0- Day 22
Volume of distribution after IV dosing
Pharmacokinetic parameter - apparent volume of distribution
Time frame: Day 0 to Day 73
Vss/F and Vz/F for subcutaneous doses
7 secondary outcomes
Pharmacokinetic parameter - Cmax
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - tmax
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - AUC
Time frame: Day 0 to Day 73
Pharmacodynamic parameter - plasma citrulline levels
Time frame: Day 0 to Day 73
ADA incidence
Time frame: Day 0 to Day 73
Safety and tolerability - AEs
Time frame: Day 0 to Day 73
Safety and tolerability - ECGs
Time frame: Day 0 to Day 73
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 22 Dec 2017.
- Derived from this study: PubMed 36323988Agersnap MA, Sonne K, Knudsen KM, Knudsen CB, Berner-Hansen M. Pharmacokinetics of Glepaglutide, A Long-Acting Glucagon-Like Peptide-2 Analogue: A Study in Healthy Subjects. Clin Drug Investig. 2022 Dec;42(12):1093-1100. doi: 10.1007/s40261-022-01210-1. Epub 2022 Nov 2.
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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 Glepaglutide in people with Healthy Subjects, run by Zealand Pharma at 1 site in United States.
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 6 inclusion and 16 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 22 Dec 2017. 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 United States. 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?
Pharmacokinetic parameter - half life (time frame: Day 0 up to Day 73). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279302, which also lists 1 linked publication.
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 22 Dec 2017.