Clinical trial NCT03877562: The Effect of CORT118335 on Olanzapine-Induced Weight Gain
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Antipsychotic-induced Weight Gain
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-03-15
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Mean Change from Baseline in Body Weight
timeFrame: Pre-dose on Day 1 (Baseline) and Day 15
Secondary outcomes:
measure: Percentage of Participants with One or More Adverse Events
timeFrame: Up to Day 28
measure: Percentage of Participants with One or More Serious Adverse Events
timeFrame: Up to Day 28
measure: Percentage of Participants Discontinued from the Study due to an Adverse Event
timeFrame: Up to Day 28
measure: Mean Change from Baseline in Glucose
timeFrame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
measure: Mean Change from Baseline in Insulin
timeFrame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
measure: Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
measure: Mean Change from Baseline in Triglycerides
timeFrame: Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28
measure: Mean Change from Baseline in Waist-to-Hip Ratio
timeFrame: Pre-dose on Day 1 (Baseline), Days 8, 15, and 28
measure: Plasma Pharmacokinetics (PK) of CORT118335: Time from Dosing at which Maximum Concentration is Apparent (tmax)
timeFrame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
measure: Plasma PK of CORT118335: Maximum Observed Concentration (Cmax)
timeFrame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
measure: Plasma PK of CORT118335: Area Under the Concentration-Time Curve Over the Dose Interval (AUCtau)
timeFrame: Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
affiliation: Quotient Sciences
name: Sharan Sidhu, MBChB, BAO, MRCS, MFPM
role: PRINCIPAL_INVESTIGATOR
References: