A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
96
1 country
1
Study Start
April 1, 2019
Actual (reported)Primary Completion
March 13, 2020
Actual (reported)Study Completion
March 25, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 25, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 14, 2019
Actual (reported)March 15, 2019
Actual (reported)April 1, 2019
Actual (reported)March 13, 2020
Actual (reported)March 25, 2020
Actual (reported)Mean Change from Baseline in Body Weight
Pre-dose on Day 1 (Baseline) and Day 15
Percentage of Participants with One or More Adverse Events
Up to Day 28
Percentage of Participants with One or More Serious Adverse Events
Up to Day 28
Percentage of Participants Discontinued from the Study due to an Adverse Event
Up to Day 28
Mean Change from Baseline in Glucose
Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Mean Change from Baseline in Insulin
Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days.
Participants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days.
CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets
Quotient Sciences
Ruddington, Nottingham, NG11 6JS, United Kingdom
Sharan Sidhu, MBChB, BAO, MRCS, MFPM
Quotient Sciences
96 participants (actual enrollment reported by the registry).
First Submitted
March 14, 2019
First Posted
March 15, 2019
Study Start
April 1, 2019
Actual (reported)Bioequivalence Study of Olanzapine Tablets, 5 mg Under Fed Study
Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available
Contact the study team to confirm eligibility.
Primary Completion
March 13, 2020
Actual (reported)Study Completion
March 25, 2020
Actual (reported)Last Updated
April 28, 2020
Record last verified: 2020-04
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Source: ClinicalTrials.gov.
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