A Phase I Study Comparing the Relative Bioavailability of a Fixed-Dose Combination of Laroprovsta… (NCT07316608) | Clinical Trial Compass
RecruitingPhase 1
A Phase I Study Comparing the Relative Bioavailability of a Fixed-Dose Combination of Laroprovstat/Rosuvastatin vs Their Single Therapy Products in Healthy Adults
United States44 participantsStarted 2026-03-16
Plain-language summary
The purpose of this study is to assess how well laroprovstat and rosuvastatin combined in a single tablet to be taken by mouth works compared with laroprovstat and rosuvastatin individual tablets taken by mouth (relative bioavailability) in healthy adults.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Provision of signed and dated, written informed consent prior to any study-specific procedures.
* Healthy male and female participants aged 18 to 55 years (inclusive) 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, in addition to a barrier method, to avoid pregnancy from the time of first administration of study intervention until 10 days after discharge from the study site.
* Females of non-childbearing potential must be confirmed at the Screening Visit by checking if they are postmenopausal \[amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the postmenopausal range\] or by documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
* Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
Exclusion Criteria:
* History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate …
What they're measuring
1
Area under concentration time curve from time 0 to infinity (AUCinf)
Timeframe: At predefined intervals from Day 1 to Day 11
2
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
Timeframe: At predefined intervals from Day 1 to Day 11
3
Maximum observed drug concentration (Cmax)
Timeframe: At predefined intervals from Day 1 to Day 11