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Phase 1b Randomized, Placebo-controlled Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Subjects With Opioid Use Disorder

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Trial Profile

Phase 1b Randomized, Placebo-controlled Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Subjects With Opioid Use Disorder

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 Feb 2023

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At a glance

Most Recent Events

  • 01 Feb 2023 Results assessing safety, tolerability, interaction potential, and pharmacokinetics (PK) of ASP8062 in combination with buprenorphine/naloxone (B/N; Suboxone R) in patients with opioid use disorder published in the Journal of Psychopharmacology
  • 14 Dec 2021 The primary endpoints Change from baseline in blood oxygen saturation (SpO2) at Predose, 1,2,4,8,12 hours postdose and Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose, 1,2,4,8 hours postdose were added, according to ClinicalTrials.gov.
  • 14 Dec 2021 The primary endpoints Number of participants with laboratory value abnormalities and/or adverse events (AEs), Number of participants with vital sign abnormalities and/or adverse events (AEs), and Number of participants with 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs) were removed, according to ClinicalTrials.gov.

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