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Completed

NCT Number: NCT06554821

A Study to Investigate the Effect of Oral Ticagrelor on the Pharmacokinetics of Oral Rosuvastatin When Given in Healthy Participants

The purpose of this study is to measure the effect of ticagrelor on the pharmacokinetics (PK) of rosuvastatin in healthy participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, 14050, Germany

About this study

This study will be conducted at a single Clinical Unit. It includes 2 parallel arms (one for each rosuvastatin dose) and 2 treatment periods.

The study will comprise:

  • A Screening Period of maximum 28 days.
  • Period 1: It will start on Day -1. A single dose of rosuvastatin (dose 1 or dose 2) will be administered on Day 1 followed by PK sampling of rosuvastatin for 96 hours. Participants will be admitted to the Clinical Unit on Study Day -1. Period 1 will end on Study Day 5.
  • Period 2: It will start on Study Day 6. A second single dose of rosuvastatin (dose 1 or dose 2) will be administered on Day 6 followed by PK sampling of rosuvastatin for 120 hours. Ticagrelor 90 mg, twice a day will be started on Day 6 (administered concomitantly with rosuvastatin) and administered through Day 10. Period 2 will end on Study Day 12.
  • A Follow-up Visit, 4 to 7 days after discharge.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.
  • 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.

Treatment and study plan

Rosuvastatin

Drug

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 names: CRESTOR

Ticagrelor

Drug

Participants in each arm will receive ticagrelor 90 mg orally BID from Day 6 to Day 10.

Other names: BRILIQUE

Primary outcomes

  1. Area under concentration-time curve from time 0 to infinity (AUCinf)

    Time frame: From Day 1 to Day 11

    To assess the effect of ticagrelor on plasma PK (AUCinf) of rosuvastatin dose 1 and dose 2 separately, in healthy participants.

  2. Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

    Time frame: From Day 1 to Day 11

    To assess the effect of ticagrelor on plasma PK (AUClast) of rosuvastatin dose 1 and dose 2 separately, in healthy participants.

  3. Maximum observed drug concentration (Cmax)

    Time frame: From Day 1 to Day 11

    To assess the effect of ticagrelor on plasma PK (Cmax) of rosuvastatin dose 1 and dose 2 separately, in healthy participants.

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Approximately 7 weeks

    To examine the safety and tolerability of rosuvastatin alone and in combination with ticagrelor.

  2. Terminal elimination half-life (t1/2)

    Time frame: From Day 1 to Day 11

    To assess the effect of ticagrelor on the PK (t1/2) of rosuvastatin in healthy participants.

  3. Terminal rate constant (parent only) (λz)

    Time frame: From Day 1 to Day 11

    To assess the effect of ticagrelor on the PK (λz) of rosuvastatin in healthy participants.

  4. Time to reach maximum observed concentration (tmax)

    Time frame: From Day 1 to Day 11

    To assess the effect of ticagrelor on the PK (tmax) of rosuvastatin in healthy participants.

  5. Amount of drug excreted (Ae)

    Time frame: From Day 1 to Day 11

    To assess the effect of ticagrelor on the urine PK (Ae) of rosuvastatin in healthy participants.

  6. Renal clearance (Clrenal)

    Time frame: From Day 1 to Day 11

    To assess the effect of ticagrelor on the urine PK (Clrenal) of rosuvastatin in healthy participants.

  7. Percent of dose excreted

    Time frame: From Day 1 to Day 11

    To assess the effect of ticagrelor on the urine PK of rosuvastatin in healthy participants.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Parexel

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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