Study S000042

A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT03235375
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 37
Start: 2017-10-27
Primary completion: 2018-04-24
Lead sponsor: MedImmune LLC
Conditions: Renal Insufficiency
Interventions: DRUG:MEDI0382
Results posted: FALSE

Registered primary outcomes

Maximum Observed Concentration of MEDI0382 (Cmax) [0-48 hours]
Area under the Concentration Time Curve (AUC) of MEDI0382 [0-48 hours]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0018820	Pharmacokinetics and Safety of Cotadutide, a GLP-1 and Glucagon Receptor Dual Agonist, in Individuals with Renal Impairment: A Single-Dose, Phase I, Bridging Study. Klein G, Clinical pharmacokinetics	2023	Other trial	PMID 37140727 DOI	cites ClinicalTrials.gov:NCT03235375; registry reference DERIVED:37140727
R0044165	A Phase 1, Open-Label, Single-Dose Study to Evaluate Pharmacokinetics of MEDI0382 in Patients with Renal Impairment Gernot K Klein (16619241), Figshare	2019	Other trial		cites ClinicalTrials.gov:NCT03235375
R0047188	1027-P: A Phase 1, Open-Label, Single-Dose Study to Evaluate Pharmacokinetics of MEDI0382 in Patients with Renal Impairment Gernot Klein, Diabetes	2019	Other trial	DOI	cites ClinicalTrials.gov:NCT03235375