| Trial ID: | L0226 |
| Source ID: | NCT04699032
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| Associated Drug: |
Apraglutide
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| Title: |
Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT04699032/results
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| Conditions: |
Chronic Kidney Disease
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| Interventions: |
DRUG: Apraglutide
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| Outcome Measures: |
Primary: Maximum Plasma Concentration (Cmax) of Apraglutide, Pharmacokinetic (PK) samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures., 5 minutes pre-dose up to 240 hours after dosing on Day 1|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Apraglutide, PK samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures., 5 minutes pre-dose up to 240 hours after dosing on Day 1 | Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs), TEAEs were defined as adverse events (AEs) that occurred after dosing the participant with the study drug. Participants with more than one TEAE were counted only once using the most severe event. Vital signs, triplicate 12-lead electrocardiograms, or clinical laboratory assessments considered clinically significant by the Investigator were reported as AEs., Day 1 up to Day 14|Number of TEAEs, The Investigator used the adjectives mild, moderate, or severe to describe the maximum intensity of the AE. These were defined as follows: * Mild: did not interfere with participant's usual function * Moderate: interfered to some extent with participant's usual function * Severe: interfered significantly with participant's usual function. The Investigator systematically assessed the causal relationship of AEs to IMP/trial treatment using the definitions below: * Not related: Not reasonably related to the IMP. The AE could not medically (pharmacologically/clinically) be attributed to the IMP * Related: Reasonably related to the IMP. The AE could medically (pharmacologically/clinically) be attributed to the IMP. A serious AE (SAE) was classified as any AE that: * Resulted in death * Was life-threatening * Required or prolonged in-patient hospitalization * Resulted in persistent or significant disability/incapacity * Was a congenital anomaly/birth defect in a neo, Day 1 up to Day 14
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| Sponsor/Collaborators: |
Sponsor: VectivBio AG
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1
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| Enrollment: |
16
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2020-12-08
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| Completion Date: |
2021-07-05
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| Results First Posted: |
2023-05-15
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| Last Update Posted: |
2024-10-26
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| Locations: |
Orlando Clinical Research Center, Orlando, Florida, 32809, United States|Prism Clinical Research, Inc., Saint Paul, Minnesota, 55114, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04699032
|
