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NCT04091373 · ClinicalTrials.gov registry record · Phase 1
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT04091373 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 36 participants.
The verdict
NCT04091373, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a randomized, open label, cross-over study in healthy adult subjects to investigate cotadutide exposure after subcutaneous injection at 3 different anatomical sites. The study will be conducted at a single US center. Each subject will be randomized to receive a single SC dose of 100 μg cotadutide via a pen device according to 6 sequences of dosing. Each SC injection will be administered by a health care provider at a different injection site (arm, thigh, or abdomen) in each period. SC injection in the abdomen will be used as the reference treatment to determine the relative PK of cotadutide 100 μg SC injections in the arm and thigh. Each SC injection of cotadutide will be separated by 7 days washout. Blood samples for PK analyses of cotadutide will be taken pre dose and at 11 time points up to 48 hours after dosing (Days 3, 10, and 17).
Interventions
- COMBINATION_PRODUCT cotadutide multidose pen injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-09-27 |
| Est. Completion | 2020-03-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04091373
The ClinicalTrials.gov registry entry for NCT04091373 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 1 intervention - of which cotadutide multidose pen injection is the first listed.
NCT04091373 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04091373 about?
NCT04091373 is a clinical study titled "A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide". This is a randomized, open label, cross-over study in healthy adult subjects to investigate cotadutide exposure after subcutaneous injection at 3 different anatomical sites. The study will be conducted at a single US center. Each subject will be randomized to receive a single SC dose of 100 μg cotad...
What is the current status of trial NCT04091373?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2019-09-27. Estimated completion is 2020-03-06.
What interventions are being tested in trial NCT04091373?
The interventions under investigation include: cotadutide multidose pen injection (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04091373?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
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