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The Effect of CORT118335 on Olanzapine-Induced Weight Gain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03877562
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Antipsychotic-induced Weight Gain Drug: Olanzapine Drug: CORT118335 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : March 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: Olanzapine plus CORT118335
Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days.
 Drug: Olanzapine
Olanzapine 10 mg oral tablet

Drug: CORT118335
CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets
Placebo Comparator: Olanzapine plus Placebo
Participants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days.
 Drug: Olanzapine
Olanzapine 10 mg oral tablet

Drug: Placebo
Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change from Baseline in Body Weight [ Time Frame: Pre-dose on Day 1 (Baseline) and Day 15 ]

Secondary Outcome Measures :
  1. Percentage of Participants with One or More Adverse Events [ Time Frame: Up to Day 28 ]
  2. Percentage of Participants with One or More Serious Adverse Events [ Time Frame: Up to Day 28 ]
  3. Percentage of Participants Discontinued from the Study due to an Adverse Event [ Time Frame: Up to Day 28 ]
  4. Mean Change from Baseline in Glucose [ Time Frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28 ]
  5. Mean Change from Baseline in Insulin [ Time Frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28 ]
  6. Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28 ]
  7. Mean Change from Baseline in Triglycerides [ Time Frame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28 ]
  8. Mean Change from Baseline in Waist-to-Hip Ratio [ Time Frame: Pre-dose on Day 1 (Baseline), Days 8, 15, and 28 ]
  9. Plasma Pharmacokinetics (PK) of CORT118335: Time from Dosing at which Maximum Concentration is Apparent (tmax) [ Time Frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7 ]
  10. Plasma PK of CORT118335: Maximum Observed Concentration (Cmax) [ Time Frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7 ]
  11. Plasma PK of CORT118335: Area Under the Concentration-Time Curve Over the Dose Interval (AUCtau) [ Time Frame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index 18.0 to 25.0 kg/m^2, inclusive
  • Stable body weight as indicated by assessment at screening and pre-dose
  • Able to swallow the size and number of tablets required
  • Provide written informed consent and agree to adhere to study restrictions and contraception requirements.

Exclusion Criteria:

  • Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT118335 at any time
  • Employee, or immediate family member of a study site or Sponsor employee
  • Have a pregnant partner
  • History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
  • Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
  • Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
  • History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, or gastrointestinal disease, neurological or psychiatric disorder
  • History of jaundice or gallstones or had a cholecystectomy
  • Family history or known risk for narrow angle glaucoma
  • Consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months
  • Any condition that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism (e.g., asthma, any chronic inflammatory condition, postural hypotension/orthostatic symptoms)
  • Presence or history of clinically significant allergy
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Are taking, or have taken, any prescribed or over-the-counter drug within 14 days other than paracetamol or standard dose multivitamins. Longer restrictions apply for some medicines.
  • Lactose intolerance.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877562


Locations
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United Kingdom
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Principal Investigator: Sharan Sidhu, MBChB, BAO, MRCS, MFPM Quotient Sciences
More Information
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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT03877562    
Other Study ID Numbers: CORT118335-852
2019-000633-39 ( EudraCT Number )
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Weight Gain
Body Weight Changes
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents