High Risk Coronary Artery DiseasePhase 1NCT02963116
A Study to Estimate the Effect of AZD5718 on the Pharmacokinetics (What Does the Body Does to the Drug) of Rosuvastatin to Measure the Relative Bioavailability (the Extent to Which a Drug or Other Substance Becomes Available to the Body) of AZD5718 Oral Suspension vs AZD5718 Immediate Release Tablet
A Phase 1 study testing AZD5718 IR tablet, AZD5718 oral suspension and Rosuvastatin tablet in people with High Risk Coronary Artery Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center, crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs AZD5718 immediate release (IR) Tablet Formulation and the… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- High Risk Coronary Artery Disease
- What is being tested?
- AZD5718 IR tablet, AZD5718 oral suspension and Rosuvastatin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Dec 2016to 1 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For inclusion in the study, subjects should fulfill the following criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and/or female subjects (of non childbearing potential) aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria 3.1. Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone levels in the postmenopausal range.
- 3.2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral ophorectomy or bilateral salpingectomy but excluding bilateral tubal ligation.
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive.
- Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study.
Who cannot join
- Subjects will not enter the study if any of the following exclusion criteria are fulfilled:
- History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at the Screening Visit and/or admission to the study unit as judged by the PI including: - Aminotransferase (ALT) > upper limit of normal (ULN); - Aspartate aminotransferase (AST) > ULN; - Total bilirubin (TBL) > ULN; and - Gamma glutamyl transpeptidase (GGT) > ULN.
- Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the study unit, as judged by the PI defined as any of the following: - Systolic BP (SBP) < 90 mmHg or ≥ 140 mmHg; - Diastolic BP (DBP) < 50 mmHg or ≥ 90 mmHg; and - Pulse < 45 or > 85 beats per minute (bpm).
Show all 21Show fewer
- Any clinically significant abnormalities (at the Screening Visit and admission) in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
- Subjects with myopathy.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.
- Plasma donation within 1 month of the Screening Visit or any blood donation/loss more than 500 mL during the 3 months prior to the Screening Visit.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718 and/or rosuvastatin.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to the Screening Visit.
- Positive screen for drugs of abuse or cotinine at the Screening Visit or on each admission to the study center or positive screen for alcohol on each admission to the study center.
- Excessive intake of caffeine containing drinks or food (e.g., coffee, tea, chocolate), as judged by the investigator.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
- Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life. Note: Hormonal replacement therapy is not allowed for females.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI.
- Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives. 19. Subjects who have previously received AZD5718.
- 20. Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- 21. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order In addition, the following is considered a criterion for the exclusion from the optional genetic component of the study: 22. Previous bone marrow transplant. 23. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection or previous bone marrow transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, 5-Period, 5-Treatment, Single-Dose, Open-Label, Single-Center, Crossover Study to Estimate the Effect of AZD5718 on the Pharmacokinetics of Rosuvastatin, and to Assess the Relative Bioavailability of AZD5718 Oral Suspension vs AZD5718 IR Tablet Formulation and the Food Effect of AZD5718.
This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center, crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy Volunteers. The study will be performed at a single study center.
Read the detailed description
The study will comprise:
- A Screening period of maximum 28 days;
- Five treatment periods during which subjects will be resident from the morning on the day before dosing with the IMP (Day -1) until at least 48 hours after dosing; discharge will be on the morning of Day 3, and
- A Follow-up Visit within 7 to 10 days after the last administration of the IMPs.
- There will be a minimum of a 7 days washout between each treatment period.
Each subject will receive 5 treatments. The following treatments will be given:
- Treatment A: 10 mg rosuvastatin tablet alone (fasting state)
- Treatment B: 10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)
- Treatment C: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)
- Treatment D: 200 mg of AZD5718 oral suspension 50 mg/mL (fasting state)
- Treatment E: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state)
Each subject will be involved in the study for approximately 8 weeks.
- Conditions
- High Risk Coronary Artery Disease
- Being tested
- AZD5718 IR tablet, AZD5718 oral suspension, Rosuvastatin tablet
- Keywords
- Pharmacokinetics (PK), Bioavailability (BA), Safety, Tolerability, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5718 IR tabletDrug
AZD5718 oral suspensionDrug
Rosuvastatin tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 10 mg rosuvastatin tablet alone (fasting state) Receives: Drug: Rosuvastatin tablet |
| Treatment B | Experimental | 10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state) Receives: Drug: AZD5718 IR tablet; Drug: Rosuvastatin tablet |
| Treatment C | Experimental | 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state) Receives: Drug: AZD5718 IR tablet |
| Treatment D | Experimental | 200 mg of AZD5718 oral suspension 50 mg/mL (fasting state) Receives: Drug: AZD5718 oral suspension |
| Treatment E | Experimental | 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state) Receives: Drug: AZD5718 IR tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve from time zero to infinity (AUC) of Rosuvastatin
Assessment of AUC of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.
Measured: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of Rosuvastatin
Assessment of AUC(0-last) of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.
Measured: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose
Maximum observed plasma concentration (Cmax) of Rosuvastatin
Assessment of Cmax of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.
Measured: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose
Secondary outcomes (14)
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½) of Rosuvastatin -
Assessment of t½ of rosuvastatin.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose. (Only Treatment A and B)
Time to reach maximum observed plasma concentration (tmax) of rosuvastatin
Assessment of tmax of rosuvastatin.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose. (Only Treatment A and B)
AUC of AZD5718
Assessment of AUC of AZD5718.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
AUC(0-last) of AZD5718
Assessment of AUC(0-last) of AZD5718.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
Cmax of AZD5718
Assessment of Cmax of AZD5718.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
tmax of AZD5718
Assessment of tmax of AZD5718.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
t½ of AZD5718
Assessment of t½ of AZD5718.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD5718
Assessment of CL/F of AZD5718.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD5718
Assessment of Vz/F of AZD5718.
Measured: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
Adverse events (AEs)
Assessment of the safety in terms of the incidences of the AEs.
Measured: Screening, Day -1 and Days 1 to 3 (treatment periods 1 to 5) and follow up visit (7-10 days post final dose)
Vital signs (systolic and diastolic blood pressure, pulse rate and body temperature)
Assessment of the safety in terms of the Vital signs (systolic and diastolic blood pressure, pulse rate).
Measured: Screening, Day -1, Pre-dose, 48 h post-dose and Follow-up visit (7-10 days post final dose)
Electrocardiogram (ECG)
Assessment of the safety in terms of the ECG.
Measured: Screening, Day -1, Pre-dose, 48 h post-dose and Follow-up visit (7-10 days post final dose)
Physical examination
Assessment of the safety in terms of the physical examination.
Measured: Screening, Day -1 (brief), 48 h (brief) post-dose
Laboratory assessments (hematology, clinical chemistry and urinalysis).
Assessment of the safety in terms of the Clinical laboratory assessments (hematology, clinical chemistry and urinalysis).
Measured: Screening, Day -1 (only limited clinical laboratory evaluations will be performed), Pre-dose, 48 h post-dose and Follow-up Visit (7-10 days post final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start20 Dec 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Risk Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Muna Albayaty, MBChB, MSc, MFPM, Principal investigator, PAREXEL Early Phase Clinical Unit London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963116
- Sponsor's protocol ID
- D7550C00002
- Status last verified
- Mar 2017
- First submitted
- 4 Nov 2016
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ericsson H, Nelander K, Heijer M, Kjaer M, Lindstedt EL, Albayaty M, Forte P, Lagerstrom-Fermer M, Skrtic S. Phase 1 Pharmacokinetic Study of AZD5718 in Healthy Volunteers: Effects of Coadministration With Rosuvastatin, Formulation and Food on Oral Bioavailability. Clin Pharmacol Drug Dev. 2020 Apr;9(3):411-421. doi: 10.1002/cpdd.756. Epub 2019 Dec 2.
PubMed 31793171
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 5-Period, 5-Treatment, Single-Dose, Open-Label, Single-Center, Crossover Study to Estimate the Effect of AZD5718 on the Pharmacokinetics of Rosuvastatin, and to Assess the Relative Bioavailability of AZD5718 Oral Suspension vs AZD5718 IR Tablet Formulation and the Food Effect of AZD5718.
- ClinicalTrials.gov ID
- NCT02963116
- Acronym / sponsor ID
- D7550C00002
- Conditions
- High Risk Coronary Artery Disease
- Keywords
- Pharmacokinetics (PK), Bioavailability (BA), Safety, Tolerability, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, open-label, 5-period, 5-treatment, single-dose, single-center, crossover study to estimate the effect of AZD5718 on the pharmacokinetics (PK) of rosuvastatin, and to assess the relative bioavailability of AZD5718 oral suspension vs AZD5718 immediate release (IR) Tablet Formulation and the Food Effect of AZD5718 in Healthy Volunteers. The study will be performed at a single study center.
Detailed description
The study will comprise:
- A Screening period of maximum 28 days;
- Five treatment periods during which subjects will be resident from the morning on the day before dosing with the IMP (Day -1) until at least 48 hours after dosing; discharge will be on the morning of Day 3, and
- A Follow-up Visit within 7 to 10 days after the last administration of the IMPs.
- There will be a minimum of a 7 days washout between each treatment period.
Each subject will receive 5 treatments. The following treatments will be given:
- Treatment A: 10 mg rosuvastatin tablet alone (fasting state)
- Treatment B: 10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)
- Treatment C: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state)
- Treatment D: 200 mg of AZD5718 oral suspension 50 mg/mL (fasting state)
- Treatment E: 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state)
Each subject will be involved in the study for approximately 8 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Rosuvastatin tablet10 mg rosuvastatin tablet alone (fasting state) |
| Treatment B | Experimental | Drug: AZD5718 IR tablet, Drug: Rosuvastatin tablet10 mg rosuvastatin tablet + 200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state) |
| Treatment C | Experimental | Drug: AZD5718 IR tablet200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fasting state) |
| Treatment D | Experimental | Drug: AZD5718 oral suspension200 mg of AZD5718 oral suspension 50 mg/mL (fasting state) |
| Treatment E | Experimental | Drug: AZD5718 IR tablet200 mg of AZD5718 IR tablet (2 x 100 mg tablet) (fed state) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and/or female subjects (of non childbearing potential) aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria 3.1. Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone levels in the postmenopausal range.
- 3.2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral ophorectomy or bilateral salpingectomy but excluding bilateral tubal ligation.
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive.
Key exclusion criteria (21 listed)
- Subjects will not enter the study if any of the following exclusion criteria are fulfilled:
- History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at the Screening Visit and/or admission to the study unit as judged by the PI including: - Aminotransferase (ALT) > upper limit of normal (ULN); - Aspartate aminotransferase (AST) > ULN; - Total bilirubin (TBL) > ULN; and - Gamma glutamyl transpeptidase (GGT) > ULN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD5718 IR tablet | Drug | Treatment B, Treatment C, Treatment E |
| AZD5718 oral suspension | Drug | Treatment D |
| Rosuvastatin tablet | Drug | Treatment A, Treatment B |
Primary outcome
Area under plasma concentration-time curve from time zero to infinity (AUC) of Rosuvastatin
Time frame: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose
Assessment of AUC of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-last)] of Rosuvastatin
Time frame: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose
Assessment of AUC(0-last) of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.
Maximum observed plasma concentration (Cmax) of Rosuvastatin
Time frame: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose
Assessment of Cmax of rosuvastatin when administered alone and in combination with AZD5718 in healthy volunteers.
14 secondary outcomes
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½) of Rosuvastatin -
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose. (Only Treatment A and B)
Time to reach maximum observed plasma concentration (tmax) of rosuvastatin
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose. (Only Treatment A and B)
AUC of AZD5718
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
AUC(0-last) of AZD5718
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
Cmax of AZD5718
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
tmax of AZD5718
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
t½ of AZD5718
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD5718
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD5718
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose (Only Treatment B, C, D, and E)
Adverse events (AEs)
Time frame: Screening, Day -1 and Days 1 to 3 (treatment periods 1 to 5) and follow up visit (7-10 days post final dose)
Vital signs (systolic and diastolic blood pressure, pulse rate and body temperature)
Time frame: Screening, Day -1, Pre-dose, 48 h post-dose and Follow-up visit (7-10 days post final dose)
Electrocardiogram (ECG)
Time frame: Screening, Day -1, Pre-dose, 48 h post-dose and Follow-up visit (7-10 days post final dose)
Physical examination
Time frame: Screening, Day -1 (brief), 48 h (brief) post-dose
Laboratory assessments (hematology, clinical chemistry and urinalysis).
Time frame: Screening, Day -1 (only limited clinical laboratory evaluations will be performed), Pre-dose, 48 h post-dose and Follow-up Visit (7-10 days post final dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 31793171Ericsson H, Nelander K, Heijer M, Kjaer M, Lindstedt EL, Albayaty M, Forte P, Lagerstrom-Fermer M, Skrtic S. Phase 1 Pharmacokinetic Study of AZD5718 in Healthy Volunteers: Effects of Coadministration With Rosuvastatin, Formulation and Food on Oral Bioavailability. Clin Pharmacol Drug Dev. 2020 Apr;9(3):411-421. doi: 10.1002/cpdd.756. Epub 2019 Dec 2.
Related trials for High Risk Coronary Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk
Atherosclerosis, Cardiovascular Diseases
Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Renovascular Hypertension, Renovascular Hypertension With Renal Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Muna Albayaty, MBChB, MSc, MFPM principal investigator
PAREXEL Early Phase Clinical Unit London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5718 IR tablet, AZD5718 oral suspension and Rosuvastatin tablet in people with High Risk Coronary Artery Disease, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under plasma concentration-time curve from time zero to infinity (AUC) of Rosuvastatin (time frame: Pre-dose, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 h post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02963116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.