Phase 1
Completed N=24
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
| Outcome | Result | p-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
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.