A study to investigate the effect of oral ticagrelor on the pharmacokinetics of oral rosuvastatin when given in healthy participants

Study identifier:D3560C00817

ClinicalTrials.gov identifier:NCT06554821

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

An open-label, randomised, parallel-group, fixed-sequence study to assess the effect of oral ticagrelor on the pharmacokinetics of oral rosuvastatin in healthy participants

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Rosuvastatin, Ticagrelor

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 05 Aug 2024

Estimated Primary Completion Date: 01 Oct 2024

Estimated Study Completion Date: 01 Oct 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Sept 2024 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

• Healthy participants with suitable veins for cannulation or repeated venipuncture.
• All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy from the time of first administration of study intervention until 1 month after the study Follow-up Visit.
• Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
(a) Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the postmenopausal range.
(b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
• Sexually active fertile male participants with partners of childbearing potential must adhere to the specified contraception methods from the time of first administration of study intervention administration until 2 weeks after the study Follow-up Visit.
• Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.

Exclusion Criteria

• History of any clinically important disease or disorder which may either put the participant at risk or influence the results or the participant’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 important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
• Any clinically important abnormal laboratory values or vital signs.
• Any positive result on Screening for serum HBsAg OR anti-HBc antibody, indicative of active hepatitis B (i.e., participants with positive anti HBc antibody result are acceptable if anti HBc IgM antibodies are negative).
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months prior to screening.
• Known or suspected history of alcohol or drug abuse or excessive intake of alcohol. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for females.
• Positive screen for drugs of abuse, or alcohol or cotinine at screening or on admission to the Clinical Unit.

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Arms	Assigned Interventions
Experimental: Rosuvastatin (Dose 1) + Ticagrelor Participants will receive rosuvastatin (dose 1) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. During Period 2, participants will also receive ticagrelor 90 mg BID (twice a day) on Day 6 through Day 10.	Drug: Rosuvastatin Participants will receive rosuvastatin (dose 1 or dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. Other Name: CRESTOR Drug: Ticagrelor Participants in each arm will receive ticagrelor 90 mg orally BID from Day 6 to Day 10. Other Name: BRILIQUE
Experimental: Rosuvastatin (Dose 2) + Ticagrelor Participants will receive rosuvastatin (dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. During Period 2, participants will also receive ticagrelor 90 mg BID on Day 6 through Day 10.	Drug: Rosuvastatin Participants will receive rosuvastatin (dose 1 or dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. Other Name: CRESTOR Drug: Ticagrelor Participants in each arm will receive ticagrelor 90 mg orally BID from Day 6 to Day 10. Other Name: BRILIQUE

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]