NCT04447287 is a Phase 1 clinical trial of ASP8062 in Opioid Use Disorder, sponsored by Astellas Pharma Global Development, Inc..

Who is sponsoring NCT04447287?

NCT04447287 is sponsored by Astellas Pharma Global Development, Inc..

What drugs are being tested in NCT04447287?

Interventions in NCT04447287: ASP8062, Placebo ASP8062, buprenorphine/naloxone.

What condition does NCT04447287 study?

NCT04447287 studies Opioid Use Disorder.

Is NCT04447287 still recruiting?

NCT04447287 is currently completed. Last updated 21 November 2024.

Are results published for NCT04447287?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-11-21 · How we verify

NCT04447287

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder

Completed Phase 1 Results posted Last updated 21 November 2024

What this trial tests

Phase 1 trial testing ASP8062 in Opioid Use Disorder in 23 participants. Completed in 25 November 2020.

Timeline

29 June 2020

Primary endpoint
25 November 2020

25 November 2020

Quick facts

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	23
Start date	29 June 2020
Primary completion	25 November 2020
Estimated completion	25 November 2020
Sites	1 location across United States

Drugs / interventions tested

ASP8062 — full drug profile →
Placebo ASP8062
buprenorphine/naloxone

Conditions studied

Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

Adults 18 to 60, any sex, with Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs) Primary · From first dose of study drug up to end of study visit (up to day 27)

An AE is defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled proced

TEAE

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	16
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	6
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	7
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	6
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	2

Drug-Related TEAE

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	12
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	6
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	5
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	6
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	1

Serious TEAE

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0

Drug-Related Serious TEAE

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0

TEAE Leading to Death

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0

Drug-Related TEAE Leading to Death

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0

TEAE Leading to Withdrawal of Treatment

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0

Drug-Related TEAE Leading to Withdrawal of Treatment

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0

Number of Participants With Suicidal Ideation and/or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Primary · Up to day 27

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Abort

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)	0

Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose Primary · 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12

The blood oxygen saturation (SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0.2	± 2.1
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.4	± 2.3
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.3	± 1.9

Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose Primary · 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12

The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0.1	± 2.5
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.6	± 2.6
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.7	± 2.3

Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose Primary · 'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0.2	± 2.2
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.8	± 2.0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0.3	± 1.8

Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose Primary · 'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0.3	± 1.9
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.4	± 1.7
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.2	± 1.2

Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose Primary · 'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0.1	± 2.3
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.1	± 2.4
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0.7	± 1.6

Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose Primary · 'buprenorphine/naloxone': Baseline and 12 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 12 hour postdose Day 12

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	-0.6	± 1.8
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.3	± 2.5
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.5	± 0.8

Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose Primary · 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and predose Day 12

End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.

Group	Value	95% CI
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-1.3	± 4.0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0.5	± 6.1

Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose Primary · 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12

End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	1.3	± 5.8
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-0.5	± 4.0
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	3.7	± 7.2

Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose Primary · 'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	1.2	± 5.1
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	0.3	± 3.2
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	4.2	± 5.0

Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose Primary · 'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12

Group	Value	95% CI
Buprenorphine/Naloxone (Run-in Period)	0.9	± 4.9
ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	-1.0	± 2.3
Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)	5.3	± 7.9

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to end of study visit (up to day 27). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Buprenorphine/Naloxone

Serious: 0/23 (0%)

Deaths: 0/23

ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)

Serious: 0/12 (0%)

Deaths: 0/12

ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)

Serious: 0/12 (0%)

Deaths: 0/12

Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)

Serious: 0/6 (0%)

Deaths: 0/6

Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (23 terms — click to expand)

Reaction	System	Buprenorphine/Naloxone	ASP8062 in Combination Wit…	ASP8062 in Combination Wit…	Placebo ASP8062 in Combina…	Placebo ASP8062 in Combina…
Headache	Nervous system disorders	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Drug withdrawal syndrome	General disorders	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Salivary hypersecretion	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Feeling of relaxation	General disorders	—	—	—	—	—
Muscle twitching	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—
Nervousness	Psychiatric disorders	—	—	—	—	—
Dysuria	Renal and urinary disorders	—	—	—	—	—
Pollakiuria	Renal and urinary disorders	—	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—
Phlebitis	Vascular disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT04447287 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A phase 1b study to investigate the potential interactions between ASP8062 and buprenorphine/naloxone in patients with opioid use disorder.
Ito M, Walzer M, Beth Blauwet M, Spence A, et al · · 2023 · cited 1× · PMID 36738100 · DOI 10.1177/02698811221149657

Verify or expand the search:

Other trials of ASP8062

Trials testing the same drug.

NCT05096117 — Human Laboratory Study of ASP8062 for Alcohol Use Disorder · Phase 2 · completed
NCT05062577 — A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With · Phase 2 · withdrawn
NCT04003402 — A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects · Phase 1 · completed
NCT03183739 — Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects · Phase 1 · completed
NCT03092726 — A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia · Phase 2 · completed

Other recruiting trials for Opioid Use Disorder

Currently open trials in the same condition.

NCT07278518 — Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine · NA · recruiting
NCT07044466 — Social Functioning in Opioid Use Disorder · NA · recruiting
NCT07158853 — Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder · NA · recruiting
NCT06943859 — Ketamine for Opioid Use Disorder · Phase 2 · recruiting
NCT06651177 — Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder · Phase 2 · recruiting

Other Astellas Pharma Global Development, Inc. trials

Trials by the same sponsor.

NCT07488676 — A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07475806 — A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep · Phase 2 · recruiting
NCT07425574 — A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults · recruiting
NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting
NCT07287995 — A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04447287 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Global Development, Inc.
Last refreshed: 21 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04447287.

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