Trial · NCT03292016

A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes

NCT03292016, Phase 2, Completed, Sumitomo Pharma America, Inc.; results first posted 2020-08-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes. Trials, record NCT03292016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03292016

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes
NCT number: NCT03292016
Status: Completed
Phases: Phase 2
Enrollment: 8 participants, actual
Lead sponsor: Sumitomo Pharma America, Inc.
Conditions: Parkinson Disease
Interventions: APL-130277, APO-go, Apokyn
First posted: 2017-09-25
Last updated: 2020-08-13
Results first posted: 2020-08-13

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Observed Plasma Concentration (Cmax)	Day 1	Dose normalized maximum observed plasma concentration (Cmax)
Primary	Observed Time of the Maximum Concentration (Tmax)	Day 1	Time from dosing to Cmax, observed by inspection of individual subject plots of plasma concentration versus time.
Primary	Area Under the Concentration- Time Curve (AUC Last)	Day 1	area under the concentration-time curve from time zero to the last measurable plasma concentration-time curve using the linear up log down trapezoidal rule.
Primary	Area Under the Concentration- Time Curve (AUC Inf)	Day 1	area under the concentration-time curve from time zero extrapolated to infinity using the linear up log down trapezoidal rule.
Primary	Mean Residence Time (MRT)	Day 1	Mean residence time during one dosing interval calculated using the following equation: MRT = AUMCinf/AUC inf. AUMCinf is the area under the first moment (time.plasma concentration vs. time) curve.
Primary	Metabolite/Parent (M/P) Drug Concentration Ratio -Cmax	Day 1	Metabolite (apomorphine sulfate) to Parent exposure ratio, Cmax, corrected for molecular weight differences.
Primary	Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)	Day 1	Apparent total clearance of the drug from plasma extravascular administration, calculated as Dose/AUCinf.
Primary	Apparent Volume of Distribution After Non-intravenous Administration (V/F)	Day 1	Apparent volume of distribution after extravascular administration, calculated as Dose/(AUCinf \* λz).
Primary	Terminal-phase Half-life (t½)	Day 1	Terminal phase half-life, as calculated by the following equation: t½ = ln(2)/λz.
Primary	Terminal-phase Rate Constant ( λz)	Day 1	Apparent terminal elimination rate constant, determined by log linear regression of the plasma concentration versus time data that was judged to be in the log-linear elimination phase. At least 3 data points in the terminal phase will be used in the determination of the rate constant.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Observed Plasma Concentration (Cmax)	Day 1		(ng/mL)/(mg)	GEOMETRIC_LEAST_SQUARES_MEAN
PRIMARY	Observed Time of the Maximum Concentration (Tmax)	Day 1	Tmax summary statistics were summarized by dose levels and the inferential statistics was done across all dose levels.	hour	MEDIAN
PRIMARY	Area Under the Concentration- Time Curve (AUC Last)	Day 1		(hxng/mL)/(mg)	GEOMETRIC_LEAST_SQUARES_MEAN
PRIMARY	Area Under the Concentration- Time Curve (AUC Inf)	Day 1		(hxng/mL)/(mg)	GEOMETRIC_LEAST_SQUARES_MEAN
PRIMARY	Mean Residence Time (MRT)	Day 1	MRT was summarized by dose level	h	GEOMETRIC_MEAN
PRIMARY	Metabolite/Parent (M/P) Drug Concentration Ratio -Cmax	Day 1	Metabolite/Parent Cmax summarized by dose level	no unit	GEOMETRIC_MEAN
PRIMARY	Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)	Day 1	CL/F summarized by dose level	L/h	GEOMETRIC_MEAN
PRIMARY	Apparent Volume of Distribution After Non-intravenous Administration (V/F)	Day 1	V/F summarized by dose level	L	GEOMETRIC_MEAN
PRIMARY	Terminal-phase Half-life (t½)	Day 1	Terminal-phase half-life summarized by dose level	h	GEOMETRIC_MEAN
PRIMARY	Terminal-phase Rate Constant ( λz)	Day 1	terminal-phase rate constant summarized by dose level	/h	GEOMETRIC_MEAN

1 to 10 of 11Source ClinicalTrials.gov

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Results by group81

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Maximum Observed Plasma Concentration (Cmax)	APL-130277, Sublingual Thin Film		0.281	90% Confidence Interval 0.191 to 0.413	(ng/mL)/(mg)
Maximum Observed Plasma Concentration (Cmax)	Subcutaneous APOKYN		2.29	90% Confidence Interval 1.46 to 3.59	(ng/mL)/(mg)
Maximum Observed Plasma Concentration (Cmax)	Subcutaneous APO-go		2.74	90% Confidence Interval 1.82 to 4.13	(ng/mL)/(mg)
Observed Time of the Maximum Concentration (Tmax)	APL-130277, Sublingual Thin Film	APL 20 mg, APOKYN 3 mg, and APO-go 3 mg	0.75	Full Range 0.52 to 0.75	hour
Observed Time of the Maximum Concentration (Tmax)	Subcutaneous APOKYN	APL 20 mg, APOKYN 3 mg, and APO-go 3 mg	0.38	Full Range 0.25 to 0.50	hour
Observed Time of the Maximum Concentration (Tmax)	Subcutaneous APO-go	APL 20 mg, APOKYN 3 mg, and APO-go 3 mg	0.38	Full Range 0.25 to 0.50	hour
Observed Time of the Maximum Concentration (Tmax)	APL-130277, Sublingual Thin Film	APL 25 mg, APOKYN 4 mg, and APO-go 4 mg	0.63	Full Range 0.25 to 1.02	hour
Observed Time of the Maximum Concentration (Tmax)	Subcutaneous APOKYN	APL 25 mg, APOKYN 4 mg, and APO-go 4 mg	0.25	Full Range 0.25 to 0.25	hour
Observed Time of the Maximum Concentration (Tmax)	Subcutaneous APO-go	APL 25 mg, APOKYN 4 mg, and APO-go 4 mg	0.26	Full Range 0.25 to 0.27	hour
Observed Time of the Maximum Concentration (Tmax)	APL-130277, Sublingual Thin Film	APL 30 mg, APOKYN 5 mg, and APO-go 5 mg	0.75	Full Range 0.50 to 1.00	hour

1 to 10 of 81Source ClinicalTrials.gov

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Participant flow90

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention	STARTED	APL-130277, Then APOKYN, Then APO-go	1
First Intervention	STARTED	APL-130277, Then APO-go, Then APOKYN	1
First Intervention	STARTED	APOKYN, Then APL-130277, Then APO-go	2
First Intervention	STARTED	APOKYN, Then APO-go, Then APL-130277	1
First Intervention	STARTED	APO-go, Then APL-130277, Then APOKYN	1
First Intervention	STARTED	APO-go, Then APOKYN, Then APL-130277	2
First Intervention	COMPLETED	APL-130277, Then APOKYN, Then APO-go	1
First Intervention	COMPLETED	APL-130277, Then APO-go, Then APOKYN	1
First Intervention	COMPLETED	APOKYN, Then APL-130277, Then APO-go	2
First Intervention	COMPLETED	APOKYN, Then APO-go, Then APL-130277	1

1 to 10 of 90Source ClinicalTrials.gov

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Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	APL-130277, Sublingual Thin Film	1	8	1
other	Nausea	Gastrointestinal disorders	Subcutaneous APOKYN	1	7	1
other	Nausea	Gastrointestinal disorders	Subcutaneous APO-go	2	8	2
other	Injection site bruising	General disorders	APL-130277, Sublingual Thin Film	0	8	0
other	Injection site bruising	General disorders	Subcutaneous APOKYN	0	7	0
other	Injection site bruising	General disorders	Subcutaneous APO-go	1	8	1
other	Dyskinesia	Nervous system disorders	APL-130277, Sublingual Thin Film	0	8	0
other	Dyskinesia	Nervous system disorders	Subcutaneous APOKYN	0	7	0
other	Dyskinesia	Nervous system disorders	Subcutaneous APO-go	1	8	1
other	Somnolence	Nervous system disorders	APL-130277, Sublingual Thin Film	0	8	0

1 to 10 of 24Source ClinicalTrials.gov

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Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	APL-130277, Sublingual Thin Film	0	8
Total, all-cause mortality	Subcutaneous APOKYN	0	7
Total, all-cause mortality	Subcutaneous APO-go	0	8
Total, other adverse events	APL-130277, Sublingual Thin Film	1	8
Total, other adverse events	Subcutaneous APOKYN	1	7
Total, other adverse events	Subcutaneous APO-go	3	8
Total, serious adverse events	APL-130277, Sublingual Thin Film	1	8
Total, serious adverse events	Subcutaneous APOKYN	0	7
Total, serious adverse events	Subcutaneous APO-go	0	8

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33991326	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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