A Single-Center, Double-Blind, Randomized, Crossover, Human Abuse Potential Trial Assessing the Pharmacokinetics and Pharmacodynamic Effects of Intravenous (IV) Administration of KP415 Prodrug, D-Methylphenidate Hydrochloride and Placebo in Recreational Stimulant Users
Phase of Trial: Phase I
Latest Information Update: 24 Oct 2018
At a glance
- Drugs Serdexmethylphenidate (Primary) ; Dexmethylphenidate
- Indications Attention-deficit hyperactivity disorder
- Focus Pharmacodynamics; Registrational
- Sponsors KemPharm
- 24 Oct 2018 Results presented in a KemPharm media release.
- 24 Oct 2018 According to a KemPharm media release, data from the study will be presented at the 65th Annual American Academy of Child and Adolescent Psychiatry (AACAP) Meeting 2018.
- 17 Sep 2018 According to a KemPharm media release, the company will present the data from all three HAP trials, as well as tampering study results, to the U.S. Food and Drug Administration (FDA) as part of its human abuse potential assessment for SDX in the KP415 New Drug Application (NDA). The NDA filing is anticipated as early as the first quarter of 2019.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History