Diabetes Mellitus, Type 2
Conditions
Keywords
JTT-662, Diabetes, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy
Interventions
DRUGJTT-662
Active drug tablets containing JTT-662
DRUGPlacebo
Placebo tablets matching in appearance to the active drug tablets
Sponsors
Akros Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit * Currently treated with a stable oral dose of metformin monotherapy for at least 12 weeks prior to the Screening Visit and until Day -3 * Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the Screening Visit * Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening Visit and on Day -3 * Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)
Exclusion criteria
* Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes of the Young or secondary forms of diabetes * Known medical history or presence of diabetic complications * Have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the Screening Visit or from the Screening Visit to Day -3 * Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or diastolic blood pressure of at least 95 mmHg) at the Screening Visit * Have impaired renal function (estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events | 6 Weeks (from Day -1 to the follow-up visit on Day 42) | Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1. |
| Number of Stools and Type of Stools Based on Bristol Stool Chart | 7 Weeks (from Day -6 to the follow-up visit on Day 42) | Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea. |
| Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | 28 Days | Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups. |
| Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Days 1, 14 and 28 | Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo. |
Countries
United States
Participant flow
Recruitment details
Written informed consent was obtained prior to performing any study-related procedures. A copy of the informed consent was provided to each subject enrolled in this study. To qualify for the study, subjects were required to satisfy defined criteria.
Pre-assignment details
Following informed consent signing, screening procedures to confirm eligibility were performed. All subjects received a single dose of placebo on Day -1 (Placebo Run-in Period) followed by JTT-662 or placebo once-daily (QD) for 28 consecutive days (Day 1 through Day 28).
Participants by arm
| Arm | Count |
|---|---|
| JTT-662 5 mg JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1 | 9 |
| JTT-662 10 mg JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1 | 9 |
| JTT-662 20 mg JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1 | 10 |
| Placebo Placebo orally once daily from Day -1 to Day 28 | 9 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Noncompliant with study requirements | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | JTT-662 5 mg | JTT-662 10 mg | JTT-662 20 mg | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 8 Participants | 10 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 9 Participants | 9 Participants | 10 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 9 Participants | 9 Participants | 8 Participants | 34 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 3 Participants | 6 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 37 |
| other Total, other adverse events | 4 / 9 | 7 / 9 | 10 / 10 | 6 / 9 | 3 / 37 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 37 |
Outcome results
Primary
Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo.
Time frame: Days 1, 14 and 28
Population: PD Population consists of subjects who were randomly assigned to treatment, received at least one dose of JTT-662 or placebo starting on Day 1 and had evaluable PD data. For the JTT-662 20 mg group, number of participants analyzed on Day 28 is 9 since 1 subject did not complete the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| JTT-662 5 mg | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 1 | -0.34 mg*hr/dL |
| JTT-662 5 mg | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 28 | -61.17 mg*hr/dL |
| JTT-662 5 mg | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 14 | -31.22 mg*hr/dL |
| JTT-662 10 mg | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 1 | -98.24 mg*hr/dL |
| JTT-662 10 mg | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 28 | -230.87 mg*hr/dL |
| JTT-662 10 mg | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 14 | -169.40 mg*hr/dL |
| JTT-662 20 mg | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 14 | -253.57 mg*hr/dL |
| JTT-662 20 mg | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 1 | -88.19 mg*hr/dL |
| JTT-662 20 mg | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 28 | -250.64 mg*hr/dL |
| Placebo | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 1 | 1.78 mg*hr/dL |
| Placebo | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 28 | -1.83 mg*hr/dL |
| Placebo | Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28 | Day 14 | -31.55 mg*hr/dL |
Comparison: Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 1p-value: 0.95695% CI: [-79.67, 75.42]Mixed Models Analysis
Comparison: Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 14p-value: 0.99595% CI: [-105.41, 106.07]Mixed Models Analysis
Comparison: Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 28p-value: 0.36695% CI: [-191.15, 72.45]Mixed Models Analysis
Comparison: Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 1p-value: 0.01695% CI: [-179.96, -20.08]Mixed Models Analysis
Comparison: Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 14p-value: 0.01495% CI: [-245.28, -30.43]Mixed Models Analysis
Comparison: Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 28p-value: 0.00195% CI: [-362.17, -95.91]Mixed Models Analysis
Comparison: Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 1p-value: 0.02595% CI: [-167.62, -12.33]Mixed Models Analysis
Comparison: Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 14p-value: <0.00195% CI: [-326.54, -117.51]Mixed Models Analysis
Comparison: Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 28p-value: <0.00195% CI: [-379.35, -118.28]Mixed Models Analysis
Primary
Number of Stools and Type of Stools Based on Bristol Stool Chart
Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea.
Time frame: 7 Weeks (from Day -6 to the follow-up visit on Day 42)
Population: Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| JTT-662 5 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 4 | 226 Number of stools |
| JTT-662 5 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 3 | 41 Number of stools |
| JTT-662 5 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 2 | 31 Number of stools |
| JTT-662 5 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 7 | 42 Number of stools |
| JTT-662 5 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 6 | 73 Number of stools |
| JTT-662 5 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 5 | 63 Number of stools |
| JTT-662 5 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 1 | 15 Number of stools |
| JTT-662 5 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Total Number of Stools | 491 Number of stools |
| JTT-662 10 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 7 | 130 Number of stools |
| JTT-662 10 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Total Number of Stools | 550 Number of stools |
| JTT-662 10 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 1 | 3 Number of stools |
| JTT-662 10 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 2 | 12 Number of stools |
| JTT-662 10 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 3 | 21 Number of stools |
| JTT-662 10 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 4 | 173 Number of stools |
| JTT-662 10 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 5 | 117 Number of stools |
| JTT-662 10 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 6 | 94 Number of stools |
| JTT-662 20 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 6 | 242 Number of stools |
| JTT-662 20 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 1 | 9 Number of stools |
| JTT-662 20 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 4 | 119 Number of stools |
| JTT-662 20 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 7 | 310 Number of stools |
| JTT-662 20 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 5 | 106 Number of stools |
| JTT-662 20 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Total Number of Stools | 815 Number of stools |
| JTT-662 20 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 2 | 11 Number of stools |
| JTT-662 20 mg | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 3 | 18 Number of stools |
| Placebo | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 1 | 4 Number of stools |
| Placebo | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 3 | 102 Number of stools |
| Placebo | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 5 | 97 Number of stools |
| Placebo | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 6 | 25 Number of stools |
| Placebo | Number of Stools and Type of Stools Based on Bristol Stool Chart | Total Number of Stools | 599 Number of stools |
| Placebo | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 4 | 329 Number of stools |
| Placebo | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 7 | 25 Number of stools |
| Placebo | Number of Stools and Type of Stools Based on Bristol Stool Chart | Type 2 | 17 Number of stools |
Primary
Number of Subjects With Treatment-emergent Adverse Events
Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.
Time frame: 6 Weeks (from Day -1 to the follow-up visit on Day 42)
Population: Safety Population consists of subjects who were randomly assigned to treatment and who received at least one dose of study drug.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JTT-662 5 mg | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with TEAEs | 4 Participants |
| JTT-662 5 mg | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with no TEAEs | 5 Participants |
| JTT-662 10 mg | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with TEAEs | 7 Participants |
| JTT-662 10 mg | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with no TEAEs | 2 Participants |
| JTT-662 20 mg | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with TEAEs | 10 Participants |
| JTT-662 20 mg | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with no TEAEs | 0 Participants |
| Placebo | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with no TEAEs | 3 Participants |
| Placebo | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with TEAEs | 6 Participants |
| Placebo Run-in | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with TEAEs | 3 Participants |
| Placebo Run-in | Number of Subjects With Treatment-emergent Adverse Events | Number of subjects with no TEAEs | 34 Participants |
Primary
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups.
Time frame: 28 Days
Population: PK Population consists of subjects randomized to JTT-662 treatment groups who received at least one dose of JTT-662 and had available PK data. The number of subjects on Days 21 and 28 is only 27 since 1 subject in the JTT-662 20 mg group discontinued the study on Day 19.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| JTT-662 5 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 28 | 292 ng/mL | Standard Deviation 103 |
| JTT-662 5 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 7 | 209 ng/mL | Standard Deviation 61.5 |
| JTT-662 5 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 21 | 281 ng/mL | Standard Deviation 100 |
| JTT-662 5 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 1 | 60.2 ng/mL | Standard Deviation 14.4 |
| JTT-662 5 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 10 | 235 ng/mL | Standard Deviation 64.3 |
| JTT-662 5 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 14 | 257 ng/mL | Standard Deviation 97.3 |
| JTT-662 5 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 15 | 266 ng/mL | Standard Deviation 83.7 |
| JTT-662 10 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 1 | 124 ng/mL | Standard Deviation 36 |
| JTT-662 10 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 15 | 689 ng/mL | Standard Deviation 209 |
| JTT-662 10 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 14 | 703 ng/mL | Standard Deviation 224 |
| JTT-662 10 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 10 | 629 ng/mL | Standard Deviation 181 |
| JTT-662 10 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 21 | 787 ng/mL | Standard Deviation 237 |
| JTT-662 10 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 28 | 786 ng/mL | Standard Deviation 326 |
| JTT-662 10 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 7 | 518 ng/mL | Standard Deviation 155 |
| JTT-662 20 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 28 | 1190 ng/mL | Standard Deviation 583 |
| JTT-662 20 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 1 | 231 ng/mL | Standard Deviation 61.9 |
| JTT-662 20 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 7 | 845 ng/mL | Standard Deviation 359 |
| JTT-662 20 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 10 | 959 ng/mL | Standard Deviation 449 |
| JTT-662 20 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 14 | 1130 ng/mL | Standard Deviation 502 |
| JTT-662 20 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 15 | 1140 ng/mL | Standard Deviation 475 |
| JTT-662 20 mg | Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28 | Day 21 | 1180 ng/mL | Standard Deviation 665 |