Trial · NCT02022748

Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects

NCT02022748, Phase 1, Completed, AstraZeneca; results first posted 2017-09-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects. Trials, record NCT02022748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02022748

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Trial

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

Title: Pharmacokinetics, Pharmacodynamics, and Safety Study of Ticagrelor in Hemodialysis Patients and Healthy Subjects
NCT number: NCT02022748
Status: Completed
Phases: Phase 1
Enrollment: 27 participants, actual
Lead sponsor: AstraZeneca
Conditions: Kidney Failure, Chronic
Interventions: ticagrelor, ticagrelor, ticagrelor
First posted: 2013-12-30
Last updated: 2018-01-17
Results first posted: 2017-09-29

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame
Primary	Pharmacokinetic Parameter Cmax of Ticagrelor	0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Primary	Pharmacokinetic Parameter Cmax of AR-C124910XX	0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Primary	Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor	0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Primary	Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX	0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose
Secondary	Pharmacokinetic Parameter t1/2 of Ticagrelor	3 days
Secondary	Pharmacokinetic Parameter t1/2 of AR-C124910XX	3 days

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pharmacokinetic Parameter Cmax of Ticagrelor	0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose	The Pharmacokinetic (PK) analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.	ng/mL	GEOMETRIC_MEAN
PRIMARY	Pharmacokinetic Parameter Cmax of AR-C124910XX	0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose	The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.	ng/mL	GEOMETRIC_MEAN
PRIMARY	Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor	0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose	The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.	ng*h/mL	GEOMETRIC_MEAN
PRIMARY	Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX	0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose	The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.	ng*h/mL	GEOMETRIC_MEAN
SECONDARY	Pharmacokinetic Parameter t1/2 of Ticagrelor	3 days	The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.	hour	MEAN
SECONDARY	Pharmacokinetic Parameter t1/2 of AR-C124910XX	3 days	The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.	hour	MEAN

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Value	Spread	Units
Pharmacokinetic Parameter Cmax of Ticagrelor	Treatment A	560.32	Geometric Coefficient of Variation 54.0	ng/mL
Pharmacokinetic Parameter Cmax of Ticagrelor	Treatment B	598.35	Geometric Coefficient of Variation 47.9	ng/mL
Pharmacokinetic Parameter Cmax of Ticagrelor	Treatment H	370.76	Geometric Coefficient of Variation 37.3	ng/mL
Pharmacokinetic Parameter Cmax of AR-C124910XX	Treatment A	130.82	Geometric Coefficient of Variation 38.3	ng/mL
Pharmacokinetic Parameter Cmax of AR-C124910XX	Treatment B	152.25	Geometric Coefficient of Variation 54.3	ng/mL
Pharmacokinetic Parameter Cmax of AR-C124910XX	Treatment H	111.73	Geometric Coefficient of Variation 60.0	ng/mL
Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor	Treatment A	3015.1	Geometric Coefficient of Variation 54.2	ng*h/mL
Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor	Treatment B	3256.1	Geometric Coefficient of Variation 52.5	ng*h/mL
Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor	Treatment H	2188.8	Geometric Coefficient of Variation 22.6	ng*h/mL
Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX	Treatment A	1127.8	Geometric Coefficient of Variation 39.3	ng*h/mL

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Sequence 1 (AB)	8
Overall Study	STARTED	Sequence 2 (BA)	6
Overall Study	STARTED	Treatment H	13
Overall Study	Subject Who Started Treatment	Sequence 1 (AB)	8
Overall Study	Subject Who Started Treatment	Sequence 2 (BA)	6
Overall Study	Subject Who Started Treatment	Treatment H	13
Overall Study	Subjects Who Completed Treatment	Sequence 1 (AB)	7
Overall Study	Subjects Who Completed Treatment	Sequence 2 (BA)	4
Overall Study	Subjects Who Completed Treatment	Treatment H	13
Overall Study	COMPLETED	Sequence 1 (AB)	7

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events39

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
other	Fluid overload	Metabolism and nutrition disorders	Treatment A	1	12
other	Fluid overload	Metabolism and nutrition disorders	Treatment B	0	13
other	Fluid overload	Metabolism and nutrition disorders	Treatment H	0	13
other	Dizziness	Nervous system disorders	Treatment A	1	12
other	Dizziness	Nervous system disorders	Treatment B	0	13
other	Dizziness	Nervous system disorders	Treatment H	0	13
other	Headache	Nervous system disorders	Treatment A	0	12
other	Headache	Nervous system disorders	Treatment B	0	13
other	Headache	Nervous system disorders	Treatment H	1	13
other	Migraine	Nervous system disorders	Treatment A	0	12

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment A
Total, all-cause mortality	Treatment B
Total, all-cause mortality	Treatment H
Total, other adverse events	Treatment A	2	12
Total, other adverse events	Treatment B	3	13
Total, other adverse events	Treatment H	2	13
Total, serious adverse events	Treatment A	0	12
Total, serious adverse events	Treatment B	1	13
Total, serious adverse events	Treatment H	0	13

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35224730	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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