Mode
Text Size
Log in / Sign up
Phase 1 Completed N=24 Randomized Double-blind Treatment

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants

Source: ClinicalTrials.gov NCT04448561 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 7; 11; 3; 7 Participants

Summary

The primary purpose of this study was to assess the safety and tolerability of multiple doses of ASP8062 or placebo alone and in combination with a single dose of morphine. This study also assessed the potential for pharmacokinetic interaction between ASP8062 and morphine.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Adverse Events (AEs)
7; 11; 3; 7; 6; 11
PRIMARY
Number of Participants With At Least One Event of Suicidal Ideation And/or Suicidal Behavior as Assessed by The Columbia-Suicide Severity Rating Scale (C-SSRS)
0; 0; 0; 0
PRIMARY
Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose
0.4; 0.3; -0.5; -0.6
PRIMARY
Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose
0.1; -0.7; -0.5; -1.4
PRIMARY
Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose
-0.1; -0.5; -0.9; -0.6
PRIMARY
Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose
0.1; -0.2; -0.5; -1.0
PRIMARY
Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose
0.0; -0.5; -1.1; -0.5
PRIMARY
Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose
-0.4; -0.5; -1.5; -1.3
PRIMARY
Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose
NA; -1.0; NA; 0.5
PRIMARY
Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose
-0.9; 0.7; -0.4; 2.5
PRIMARY
Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose
-1.1; 2.5; -1.0; 4.1
PRIMARY
Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose
-0.8; 1.0; 0.1; 3.3
PRIMARY
Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose
0.2; 2.7; 2.1; 5.8
SECONDARY
Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration From Time of Dosing to 24 Hours (AUC24)
1640; 1640
SECONDARY
Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Plasma Concentration (Cmax)
124; 116
SECONDARY
Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration From Time of Dosing Extrapolated to Time Infinity (AUCinf)
128; 166
SECONDARY
Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)
160; 158
SECONDARY
Pharmacokinetics (PK) of Morphine in Plasma: Cmax
41.3; 42.3
SECONDARY
Pharmacokinetics (PK) of Morphine-3β-D-glucuronide(M3G) (Morphine Metabolite) in Plasma: AUCinf
5720; 6580
SECONDARY
Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: AUClast
5340; 5960
SECONDARY
Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: Cmax
933; 967
SECONDARY
Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUCinf
821; 1100
SECONDARY
Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUClast
871; 1000
SECONDARY
Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: Cmax
184; 192

Eligibility Criteria

Inclusion Criteria

  • Participant is a recreational opioid user who has used opioids for nontherapeutic (recreational) purposes on at least 10 occasions within their lifetime, with at least 1 opioid use in the last 90 days.
  • Participant has a body mass index (BMI) range of 18 to 36 kg/m^2, inclusive and weighs at least 50 kg at screening.
  • Female participant is not pregnant and at least 1 of the following conditions apply:
  • Not a woman of childbearing potential (WOCBP)
  • WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 28 days after final investigational product (IP) administration.
  • Female participant must agree not to breastfeed starting at screening and throughout the study period and for 28 days after final IP administration.
  • Female participant must not donate ova starting at first dose of IP and throughout the study period and for 28 days after final IP administration.
  • Male participant with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the treatment period and for 90 days after final IP administration.
  • Male participant must not donate sperm during the treatment period and for 90 days after final IP administration.
  • Male participant with a pregnant partner(s) must agree to remain abstinent or use a condom with spermicide for the duration of the pregnancy throughout the study period and for 90 days after final IP administration.
  • Participant agrees to not participate in another interventional study while participating in the present study.

Exclusion Criteria

  • Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
  • Participant has any condition which makes the participant unsuitable for study participation.
  • Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
  • Participant has a known or suspected hypersensitivity to ASP8062 or morphine and/or other opioids, or any components of the formulations used.
  • Participant has had previous exposure with ASP8062.
  • Participant has any of the liver function tests (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
  • Participant has any clinically significant history of allergic conditions (including drug allergies, asthma or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to first IP administration.
  • Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal and/or other major disease or malignancy with exception of history of cholecystectomy.
  • Participant has a history of moderate or severe use disorder for any substance other than caffeine or tobacco (based on the Diagnostic and Statistical Manual of Mental Disorders, edition 5 (DSM-5) criteria).
  • Participant has a history or presence of any clinically significant psychiatric disorders such as, bipolar 1, schizophrenia, schizoaffective disorder or major depressive disorders.
  • Participant has had recent suicidal ideation within the last 12 months or participant who is at significant risk to commit suicide using the Baseline/Screening Columbia-suicide severity rating scale (C-SSRS) at screening and the Since Last Visit C-SSRS on day -1.
  • Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
  • Participant has any clinically significant abnormality following an investigator's review of the physical examination, ECG and protoco
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04448561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search