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NCT03341013 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03341013 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 24 participants.
The verdict
NCT03341013, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.
Interventions
- DRUG MEDI0382 Formulation 2
- DRUG MEDI0382 Formulation 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2018-01-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03341013
The ClinicalTrials.gov registry entry for NCT03341013 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedImmune, which has 210 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MEDI0382 Formulation 2 is the first listed.
NCT03341013 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03341013 about?
NCT03341013 is a clinical study titled "A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382". This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized...
What is the current status of trial NCT03341013?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-11-30. Estimated completion is 2018-01-29.
What interventions are being tested in trial NCT03341013?
The interventions under investigation include: MEDI0382 Formulation 2 (DRUG), MEDI0382 Formulation 3 (DRUG).
Who is sponsoring clinical trial NCT03341013?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
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