A Study to Determine the Relative Bioavailability of Two New Relacorilant Capsule Variants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 9/9/2018 |
Start Date: | May 24, 2018 |
End Date: | July 25, 2018 |
A Phase 1, Randomized, Open-label, Crossover Study to Determine the Relative Bioavailability of Relacorilant Administered as 3×100-mg Softgel Capsules, 3×100 mg Hard Shell Capsules, and 6×50-mg Hard-shell Capsules in Healthy Adult Subjects
This is an open-label, randomized, 3 treatment, 3-period, 6-sequence, crossover study
conducted at a single study center to characterize the relative bioavailability of
relacorilant administered as 3×100-mg softgel capsules (Treatment A), 3×100 mg hard-shell
capsules (Treatment B), and 6×50-mg hard shell capsules (Treatment C/reference) in healthy,
fasted, adult subjects.
Eligible subjects will participate in 3 treatment periods. During each treatment period,
subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be
randomized to each of 6 sequences.
conducted at a single study center to characterize the relative bioavailability of
relacorilant administered as 3×100-mg softgel capsules (Treatment A), 3×100 mg hard-shell
capsules (Treatment B), and 6×50-mg hard shell capsules (Treatment C/reference) in healthy,
fasted, adult subjects.
Eligible subjects will participate in 3 treatment periods. During each treatment period,
subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be
randomized to each of 6 sequences.
This is an open-label, randomized, 3 treatment, 3-period, 6-sequence, crossover study.
Eligible subjects will participate in 3 treatment periods. During each treatment period,
subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be
randomized to each of 6 sequences (i.e., ABC, BCA, CAB, BAC, ACB, and CBA):
(A) relacorilant single 300 mg dose (3×100-mg softgel capsules) following a minimum 10 hour
fast (Test 1) (B) relacorilant single 300 mg dose (3×100-mg hard-shell capsules) following a
minimum 10-hour fast (Test 2) (C) relacorilant single 300 mg dose (6×50-mg hard-shell
capsules) following a minimum 10 hour fast (Reference) Subjects will be admitted to the
Clinical Research Unit (CRU) on the morning of Day −1 of each period following an 8-hour fast
for baseline assessments and will remain confined until Day 3 of each period. After dosing in
Period 1 and Period 2, subjects will undergo minimum 14 day washouts between doses of study
drug. Subjects will then receive the next relacorilant dose in their randomized sequence in
Period 2 and Period 3, respectively. Subjects will attend an outpatient Follow-up Visit 14±2
days after the last dose of study drug in Period 3 (or Early Termination Visit).
Blood samples will be collected before dosing and at intervals up to 120 hours after
relacorilant dose in Periods 1, 2 and 3.
Safety and tolerability will be monitored using AEs, clinical laboratory evaluations, 12-lead
ECG recordings, vital signs, and physical examinations.
Eligible subjects will participate in 3 treatment periods. During each treatment period,
subjects will receive a single 300-mg relacorilant dose. An equal number of subjects will be
randomized to each of 6 sequences (i.e., ABC, BCA, CAB, BAC, ACB, and CBA):
(A) relacorilant single 300 mg dose (3×100-mg softgel capsules) following a minimum 10 hour
fast (Test 1) (B) relacorilant single 300 mg dose (3×100-mg hard-shell capsules) following a
minimum 10-hour fast (Test 2) (C) relacorilant single 300 mg dose (6×50-mg hard-shell
capsules) following a minimum 10 hour fast (Reference) Subjects will be admitted to the
Clinical Research Unit (CRU) on the morning of Day −1 of each period following an 8-hour fast
for baseline assessments and will remain confined until Day 3 of each period. After dosing in
Period 1 and Period 2, subjects will undergo minimum 14 day washouts between doses of study
drug. Subjects will then receive the next relacorilant dose in their randomized sequence in
Period 2 and Period 3, respectively. Subjects will attend an outpatient Follow-up Visit 14±2
days after the last dose of study drug in Period 3 (or Early Termination Visit).
Blood samples will be collected before dosing and at intervals up to 120 hours after
relacorilant dose in Periods 1, 2 and 3.
Safety and tolerability will be monitored using AEs, clinical laboratory evaluations, 12-lead
ECG recordings, vital signs, and physical examinations.
Inclusion Criteria:
- Able to understand the purpose and risks of the study; willing and able to adhere to
scheduled visits, treatment plans, laboratory tests, and other study evaluations and
procedures.
- Give written informed consent.
- Be males or nonpregnant, nonlactating females judged to be in good health, based on
the results of medical history, physical examination, vital signs, 12-lead ECG, and
clinical laboratory findings.
- Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a body weight
more than 50 kg (110 pounds).
- Be a nonsmoker. Use of nicotine or nicotine-containing products must be discontinued
at least 90 days prior to the first dose of study drug.
- Be willing to comply with study restrictions
- Have suitable veins for multiple venipuncture/cannulation.
- Female subjects must be either of nonchildbearing potential (i.e., postmenopausal or
permanently sterilized) or use highly effective contraception with low
user-dependency.
- The only acceptable method of highly effective contraception with low
user-dependency is an intrauterine device (IUD). Use of hormonal contraception
(by any route, including intrauterine hormone releasing systems) or hormone
replacement therapy is NOT acceptable.
Exclusion Criteria:
- Be an employee or immediate family member of the Clinical Research Unit or Corcept.
- Have been previously enrolled in any study of relacorilant.
- Have multiple drug allergies or be allergic to any of the components of relacorilant.
- Have a condition that could be aggravated by glucocorticoid blockade (e.g., asthma,
any chronic inflammatory condition).
- Have a history of malabsorption syndrome or previous gastrointestinal surgery, with
the exception of appendectomy and cholecystectomy, which could affect drug absorption
or metabolism.
- Current, or previous within a 1-year period, alcohol or substance abuse.
- In the 2 calendar months before first study drug administration, have donated/lost
blood or plasma in excess of 400 mL.
- In the 30 days before first study drug administration, have participated in another
clinical trial of a new chemical entity or a prescription medicine.
- Have a positive test for alcohol or drugs of abuse at screening or first admission.
- Have clinically relevant abnormal findings on vital signs, physical examination,
laboratory screening tests, or 12-lead ECG, at screening and/or before first study
drug administration, including but not limited to**:
- QT interval corrected for heart rate (QTc) using Fridericia's equation (QTcF)
>450 ms (from mean of 3 supine ECGs, performed at least 2 minutes apart)
- Stage 2 or higher hypertension (supine/semi-recumbent systolic blood pressure
[SBP] >160 mmHg, diastolic blood pressure [DBP] >100 mmHg; based on mean of
duplicate values recorded at least 2 minutes apart)
- Stage 1 hypertension (supine/semi-recumbent SBP 140-160 mmHg, DBP 90-100 mmHg;
based on mean of duplicate values recorded at least 2 minutes apart) associated
with indication for treatment i.e., evidence of end-organ damage, diabetes, or a
10-year cardiovascular risk, estimated using a standard calculator, (e.g.,
QRISK2-2016) greater than 20%
- Estimated glomerular filtration rate <60 mL/minute/1.73 m2, estimated using the
Chronic Kidney Disease Epidemiology Collaboration method (Levey 2009)
- Hypokalemia (potassium below lower limit of normal)
- Alanine aminotransferase (ALT), aspartate amino transferase (AST), and/or gamma-
glutamyl transferase (GGT) >1.5 times the upper limit of normal (ULN)
- Seropositive for hepatitis B, hepatitis C, or human immunodeficiency (HIV)
viruses **For purposes of qualifying any given subject for study participation,
out-of-range values may be repeated once.
- Have any medical or social reasons for not participating in the study raised by their
primary care physician.
- Have any other condition that might increase the risk to the individual or decrease
the chance of obtaining satisfactory data, as assessed by the Investigator.
- Taken any prohibited prior medication within protocol designated timeframes, such as
or including any glucocorticoid, strong inducers, inhibitors or substrates of CYP
enzymes involved in drug-drug-interactions, hormonal contraception or hormone
replacement therapy.
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