A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes

NCT03292016 ↗

Phase 2 Completed 8 enrolled Sumitomo Pharma America, Inc.

RandomizedCrossoverOpen-labelTreatment

Summary

A study that compares the extent to which apomorphine becomes available in the body after taking either an investigational drug containing apomorphine or apomorphine that is injected under the skin in people with PD complicated by "OFF" episodes.

Timeline

Start: 2017-08-22
Primary completion: 2019-03-05
Completion: 2019-03-05

Publications

Agbo F, Isaacson SH, Gil R, Chiu YY, Brantley SJ, Bhargava P, Navia B. Pharmacokinetics and Comparative Bioavailability of Apomorphine Sublingual Film and Subcutaneous Apomorphine Formulations in Patients with Parkinson's Disease and "OFF" Episodes: Results of a Randomized, Three-Way Crossover, Open-Label Study. Neurol Ther. 2021 Dec;10(2):693-709. doi: 10.1007/s40120-021-00251-6. Epub 2021 May 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apomorphine	Unknown	2 mg	Other
Subject	Apomorphine	Unknown	3 mg	Other
Subject	Apomorphine	Unknown	4 mg	Other
Subject	Apomorphine	Unknown	5 mg	Other
Subject	Apomorphine	Unknown	15 mg	Other
Subject	Apomorphine	Unknown	20 mg	Other
Subject	Apomorphine	Unknown	25 mg	Other
Subject	Apomorphine	Unknown	30 mg	Other

A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes

Summary

Timeline

Publications

Drugs

Indications