Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
NCT Number: NCT04183283
The main purpose of this study is to learn more about how LY3526318 affects blood flow to the skin in healthy women. For each participant, the study will last up to 28 days and Part B will last up to 78 days, including screening and follow-up.
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Notify Me18 year–45 year
Female
Interventional
Phase 1
Leuven, 3000, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
--Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized [for example (e.g.) tubal occlusion, hysterectomy, bilateral salpingectomy] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months)
Exclusion criteria
Administered orally.
Administered orally.
Time frame: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)
CA-induced DBF was measured by laser doppler imaging (LDI). Least Squares (LS) mean was determined by analysis of variance (ANOVA) model with treatment, period, sequence, time and treatment*time interaction as fixed factors and subject within sequence as a random factor.
Time frame: 3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)
CA-induced DBF was measured by LSCI. LS mean was determined by ANOVA model with treatment, period, sequence, time and treatment*time interaction as fixed factors and subject within sequence as a random factor.
Time frame: Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318
Time frame: Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Time frame: 3 hours and 24 hours post dose
Plasma Concentrations of LY3526318 at 3 and 24 Hours
Eli Lilly and Company
Industry
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Oral Single-Doses of LY3526318 on Cinnamaldehyde-Induced Dermal Blood Flow in Healthy Females
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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