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A Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

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ClinicalTrials.gov Identifier: NCT03994549
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

Brief Summary:
This is a randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo within each cohort.

Condition or disease Intervention/treatment Phase
Healthy Drug: Dual GLP-1/GLP-2 Receptor agonists Early Phase 1

Detailed Description:
Sixty-four subjects are planned to be studied in eight cohorts in this first-in human trial. Eight subjects will be allocated to the to eight dose levels. The entire observation period comprise 28 days starting with a 96 hours in-house stay, where discharge is planned for Day 5, followed by five outpatient visits and an End of Trial Visit at Day 28. A blinded evaluation of each cohort will be performed by a Trial Safety Group to determine whether the trial will progress to the next dose level based on the stopping rules specified in protocol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of ZP7570 in Healthy Subjects
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Active Comparator: ZP7570
Single subcutaneous injection
Drug: Dual GLP-1/GLP-2 Receptor agonists
Eight ascending doses of ZP7570
Other Name: ZP7570

Placebo Comparator: Placebo
Single subcutaneous injection
Drug: Dual GLP-1/GLP-2 Receptor agonists
Eight ascending doses of ZP7570
Other Name: ZP7570




Primary Outcome Measures :
  1. Safety - Incidence of adverse events (AEs) [ Time Frame: From time zero to 28 days after dosing ]
    The incidence, type and severity of adverse events (AEs)


Secondary Outcome Measures :
  1. Pharmacokinetics - Area under the plasma concentration-time curve trough [ Time Frame: From time zero up to day 28 ]
    AUCτ, Area under the plasma concentration-time curve (AUC) from zero up to trough concentration.

  2. Pharmacokinetics - Area under the plasma concentration-time curve infinity [ Time Frame: From time zero up to day 28 ]
    AUCinf, Area under the plasma concentration-time curve (AUC) from zero up to last concentration.

  3. Pharmacokinetics - Area under the plasma concentration-time curve last [ Time Frame: From time zero up to day 28 ]
    AUClast, Area under the plasma concentration-time curve (AUC) from zero up to last concentration

  4. Pharmacokinetics - Maximum plasma concentration [ Time Frame: From time zero to 28 days after dosing ]
    Measured maximum plasma drug concentration after dosing, Cmax

  5. Pharmacokinetics - Time to maximum plasma concentration (Tmax) [ Time Frame: From time zero to 28 days after dosing ]
    Sampling time until reaching Cmax, Tmax

  6. Pharmacokinetics - Half-life , t½ [ Time Frame: From time zero to 28 days after dosing ]
    Half-life of ZP7570, t½

  7. Pharmacokinetics - Volume of distribution [ Time Frame: From time zero to 28 days after dosing ]
    Apparent volume of distribution of ZP7570, Vz/f

  8. Pharmacokinetics - Mean residence time [ Time Frame: From time zero to 28 days after dosing ]
    Mean residence time, MRT

  9. Pharmacokinetics - Body clearance [ Time Frame: From time zero to 28 days after dosing ]
    Total body clearance, CL/f

  10. Pharmacokinetics - Elimination rate constant [ Time Frame: From time zero to 28 days after dosing ]
    Elimination rate constant, λz

  11. Pharmacodynamics - Plasma glucose levels [ Time Frame: Time Frame: 0-240 minutes ]
    Plasma glucose levels included with the acetaminophen at specific timepoints relative to a Mixed Test Meal

  12. Pharmacodynamics - Insulin concentrations [ Time Frame: Time Frame: 0-240 minutes ]
    Insulin concentrations included with the acetaminophen at specific timepoints relative to a Mixed Test Meal

  13. Pharmacodynamics - Plasma acetaminophen concentration-time curves [ Time Frame: Time Frame: 0-240 minutes ]
    Plasma acetaminophen concentration-time curves following ingestion of acetaminophen

  14. Pharmacodynamics - Maximum acetaminophen concentration [ Time Frame: Time Frame: 0-240 minutes ]
    Change from baseline acetaminophen to maximum acetaminophen

  15. Pharmacodynamics - Time maximum acetaminophen concentration [ Time Frame: Time Frame: 0-240 minutes ]
    Time to maximum change in acetaminophen measure from baseline, Tmax

  16. Safety - Safety lab, haematology [ Time Frame: From time zero to 28 days after dosing ]
    Changes in haematology parameters: Haematocrit, Haemoglobin, Erythrocytes, MCV, MCH, MCHC, platelets, Leucocytes, Neutrophile granulocytes (total count and relative), Lymphocytes (total count and relative), Monocytes (total count and relative), Eosinophile granulocytes (total count and relative), Basophile granulocytes (total count and relative)

  17. Safety - Safety lab, clinical chemistry [ Time Frame: From time zero to 28 days after dosing ]
    Changes in clinical chemistry parameters: Sodium, Potassium, Calcium, Creatinine, Urea, AST, ALT, gamma-GT, Uric acid, Total protein, Albumin, Total bilirubin, Creatine kinase, Alkaline phosphatase, LDH, Total cholesterol, LDL, HDL, Amylase, Triglycerides, Lipase

  18. Safety - Safety lab, urinalysis [ Time Frame: From time zero to 28 days after dosing ]
    Changes in urinalysis: Protein, Glucose Erythrocytes, Leucocytes, pH, ketones

  19. Safety - Vital signs, blood pressure [ Time Frame: From time zero to 28 days after dosing ]
    Changes in vital signs, blood pressure (in mmHG)

  20. Safety - Vital signs, pulse [ Time Frame: From time zero to 28 days after dosing ]
    Changes in pulse (beats per minute)

  21. Safety - Physical examination [ Time Frame: From time zero to 28 days after dosing ]
    Changes in physical examination of body sections (head, chest and heart, abdomen, skin and mucosae, musculoskeletal system, nervous system, lymph node)

  22. Safety - ECG [ Time Frame: From time zero to 28 days after dosing ]
    Occurrence of ECG findings, Changes in ECG parameters (in ms). ECG components: Heart rate, PR, QRS, QT and QTcF.

  23. Safety - Occurrence of Injection site reactions [ Time Frame: From time zero to 28 days after dosing ]
    Occurrence of injection site reactions

  24. Safety - Immunogenicity: Occurrence of anti-drug antibodies [ Time Frame: From time zero to 28 days after dosing ]
    Occurrence of anti-drug antibodies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female subject aged between 18 and 55 years, both inclusive.
  • Body Mass Index (BMI) between 18.5 and 28.0 kg/m^2, both inclusive
  • Body weight of at least 60 kg.
  • Heart rate after 5 minutes rest in supine position inside the range of 50-90 beats/min at screening

Exclusion Criteria:

  • Any history of a disorder which in the investigator's opinion might jeopardize subjects safety, evaluation of results or compliance with the protocol.
  • History of gallbladder disease or cholecystectomy.
  • History of major depressive disorder or a Patient Health Questionnaire (PHQ-9) > 9 completed at screening, or a history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder).
  • Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to screening.
  • Clinically significant abnormal standard 12-lead ECG after 5 min resting in supine position at screening, including a QTcF > 450 ms (males) or QTcF > 470 ms (females), PR ≥ 220 ms and QRS ≥ 110 ms as evaluated by the investigator.
  • History of severe hypersensitivity to medicines or foods or history of severe medicinal/food induced anaphylactic reaction or contraindication to the use of Indocyanine Green (e.g. hypersensitivity to iodine).
  • Any clinically significant abnormal hematology, biochemistry, or urinalysis screening tests, as judged by the investigator.
  • TSH values outside of normal reference ranges of safety laboratory
  • Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73 m2, as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
  • Known or suspected hypersensitivity to IMP(s) or related products.
  • Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension).
  • Symptoms of arterial hypotension
  • Women of childbearing potential who are not using a highly effective contraceptive method
  • Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 28 days after dosing
  • Men with pregnant partner not willing to use male contraception (condom) until 28 days after dosing, in order to avoid exposure of the embryo/fetus to seminal fluid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994549


Contacts
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Contact: Elke Gurschke, MDRA +4921314018 ext 411 regulatory@profil.com
Contact: Ulrike Hövelmann, MD +4921314018 ext 456 ulrike.hoevelmann@profil.com

Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH Recruiting
Neuss, North Rhine-Westphalia, Germany, 41460
Contact: Simone Matern    +49 2131 4018 ext 493    simone.matern@profil.com   
Contact: Nacera Infed    +49 2131 4018 ext 385    nacera.infed@profil.com   
Sponsors and Collaborators
Zealand Pharma
Investigators
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Principal Investigator: Ulrike Hövelmann, MD Profil Neuss, Germany

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Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT03994549     History of Changes
Other Study ID Numbers: ZP7570-18144
2019-001128-36 ( EudraCT Number )
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand Pharma:
Dual GLP-1R/GLP-2 Receptor agonist
Additional relevant MeSH terms:
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Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs