This study determined the maximum dose of LCI6999 with respect to effect on the ACTH-stimulated cortisol response in participants with hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
LCI699-matching placebo oral capsules
LCI699 oral capsules
Impact Clinical Trials
Beverly Hills, California, United States
Associated Pharmaceutical Research Center, Inc
Buena Park, California, United States
Innovative Clinical Research, Inc
Harbor City, California, United States
Maximum Tolerated Dose (MTD) of LCI699 With Respect to Effect on the Adrenocorticotropic Hormone (ACTH)-Stimulated Cortisol Response Following ACTH Stimulation in Hypertensive Participants
As per the protocol, MTD is the dose at which 4 participants exhibited ACTH-stimulated cortisol results \<400 nanomoles per liter (nmol/L). The change in the distribution across the treatments were analyzed using 1- way analysis of variance (ANOVA) for continuous variables.
Time frame: Up to Week 6
LCI699 Exposure-response Relationship on Cortisol Levels Following ACTH Stimulation in Hypertensive Participants
Exposure-response relationship was assessed using ACTH stimulation test. Tests were done 2 hours after study drug administration (i.e., at peak LCI699 concentrations). An increase in cortisol greater than \>500 nmol at 60 minutes after ACTH administration was expected.
Time frame: Up to Week 6
LCI699 Plasma Concentration Post LCI699 Administration at Day 7
Time frame: Predose and 3 hours post-dose on Day 7
Maximum Plasma Concentration (Cmax) of LCI699
Time frame: Days 7, 28: Pre-dose and 3 hours post-dose; Day 30: Pre-dose; Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose
Time of Maximum Plasma Concentration (Tmax) of LCI699
Time frame: Days 7, 28: Pre-dose and 3 hours post-dose; Day 30: Pre-dose; Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose
Area Under the Concentration Time Curve From Time 0 to 8 Hours Post LCI699 Administration (AUC0-8)
Time frame: Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose
Area Under the Concentration Time Curve Over the Dosing Interval (AUC0-τ) for LCI699
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Long Beach Center for Clinical Research
Long Beach, California, United States
Metro Clinical Research
Littleton, Colorado, United States
Clinical Study Center of Asheville, LLC
Asheville, North Carolina, United States
Northstate Clinical Research
Lenoir, North Carolina, United States
Tipton Medical & Diagnostic Center
Tipton, Pennsylvania, United States
Punzi Medical Center
Carrollton, Texas, United States
dgd Research, Inc
San Antonio, Texas, United States
...and 1 more locations
Time frame: Days 7, 28: Pre-dose and 3 hours post-dose; Day 30: Pre-dose; Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose
Apparent Terminal Half-life (T1/2) of LCI699
Time frame: Days 7, 28: Pre-dose and 3 hours post-dose; Day 30: Pre-dose; Day 42: Pre-dose and 0.5, 1, 2, 3, 4, and 8-hours post-dose
Number of Participants With Adverse Event (AEs)
An AE is an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives.
Time frame: Up to 8 weeks
Percentage of Participants With a Mean Sitting Systolic Blood Pressure (MSSBP) Response and MSSBP Control at Week 6 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP)
Automated arterial BP determinations was made with an automated BP device (such as the Omron BP monitor) in accordance with the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV. Sitting and standing blood pressure (BP) and heart rate (HR) measurements were performed. MSSBP response was defined as the percentage of participants with a MSSBP \<140 mmHg or a \>=20 mmHg reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP \<140 mmHg for non-diabetic participants and \<130mHg for diabetic participants.
Time frame: Week 6
Percentage of Participants With a Mean Sitting Diastolic Blood Pressure (MSDBP) Response and MSDBP Control at Week 6 LOCF, as Measured by OBP
Automated arterial BP determinations was made with an automated BP device (such as the Omron BP monitor) in accordance with the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV. Sitting and standing BP and HR measurements were performed. MSDBP response was defined as the percentage of participants with a MSDBP \<90 mmHg or a \>= 10 mmHg reduction from baseline. MSDBP control was defined as the percentage of participants with a MSDBP \<90 mmHg for non-diabetic participants and \<80mHg for diabetic participants.
Time frame: Week 6