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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: Completed Phase 1 study, sponsored by MedImmune.
NCT04091373 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To evaluate exposure following a single subcutaneous dose of cotadutide at each of 3 different sites of injection.
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 |
What the finished NCT04091373 record still lists
NCT04091373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which cotadutide multidose pen injection is the first listed.
NCT04091373 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04091373's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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