Quotient Sciences
Ruddington, Nottingham, NG11 6JS, United Kingdom
NCT Number: NCT03877562
This study will investigate if there is any difference in the amount of weight gained by participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy test medicine which looks like CORT118335 but contains no active medicine). Safety and tolerability of CORT118335 when taken with olanzapine will also be evaluated.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Ruddington, Nottingham, NG11 6JS, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Olanzapine 10 mg oral tablet
CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets
Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available
Time frame: Pre-dose on Day 1 (Baseline) and Day 15
Time frame: Up to Day 28
Time frame: Up to Day 28
Time frame: Up to Day 28
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Time frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Time frame: Pre-dose on Day 1 (Baseline), Days 8, 15, and 28
Time frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Time frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Time frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Corcept Therapeutics
Industry
A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects
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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