Contraception, Pregnancy
Conditions
Brief summary
The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive effect when injected every 6 months.
Interventions
DRUGTV-46046 - 400 mg/mL
A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL
DRUGTV-46046 - 200 mg/mL
A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL
Sponsors
FHI 360
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* has regular menstrual cycle (24 to 35 days) * is at low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, in monogamous relationship with vasectomized partner, or using non-hormonal IUD) * is in good general health as determined by a medical history and physical examination * is not pregnant and does not have desire to become pregnant in the subsequent 36 months * has had a normal mammogram within the last year (for Part 1 only) * additional criteria apply, please contact the investigator for more information
Exclusion criteria
* has hypertension: * systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg * vascular disease * has current or history of ischemic heart disease * has history of stroke * has history of thromboembolic event * has systemic lupus erythematosus * positive (or unknown) antiphospholipid antibodies * severe thrombocytopenia * has rheumatoid arthritis on immunosuppressive therapy * has migraine with aura * has unexplained vaginal bleeding * has diabetes * has strong family history of breast cancer (defined as one or more first degree relatives, breast cancer occurring before menopause in three or more family members, regardless of degree of relationship, and any male family member with breast cancer), or current or history of breast cancer, or undiagnosed mass detected by breast exam * has current or history of cervical cancer * has severe cirrhosis (decompensated) or liver tumors * has known significant renal disease * used Depo-Provera Contraceptive Injection or Depo-subcutaneous Provera 104 (DMPA) products in the past 12 months * used any of the following medications within 1 month prior to enrollment: * any investigational drug * prohibited drugs per protocol * oral contraceptives, contraceptive ring or patch * levonorgestrel intrauterine system (LNG IUS) or contraceptive implant * used a combined injectable contraceptive in the past 6 months * less than 3 months since the end of last pregnancy * currently lactating * is using or plans to use prohibited drugs per protocol in the next 18 months * has known sensitivity to MPA or inactive ingredients * has a plan to move to another location in the next 24 months * in the opinion of the investigator, potentially at elevated risk of HIV infection (eg, HIV -positive partner, IV drug use by self or by partner) * additional criteria apply, please contact the investigator for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Serum MPA Concentration at Day 28 | Day 28 | — |
| Part 1: Serum MPA Concentration at Day 91 | Day 91 | — |
| Part 1: Serum MPA Concentration at Day 182 | Day 182 | — |
| Part 1: Serum MPA Concentration at Day 210 | Day 210 | — |
| Part 1: Maximum Observed Serum Concentration (Cmax) of MPA | Day 0 up to Week 52 | — |
| Part 1: Observed Serum Drug Concentration at Day 182 (C182) of MPA | Day 182 | — |
| Part 1: Time to Reach Cmax (Tmax) of MPA | Day 0 up to Week 52 | — |
| Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1 | Day 1 | 'Overall number of participants analyzed' = participants evaluable for this outcome measure. |
| Part 1: Serum MPA Concentration at Day 7 | Day 7 | — |
| Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 182 (AUC0-182) of MPA | Day 0 up to Day 182 | — |
| Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 210 (AUC0-210) of MPA | Day 0 up to Day 210 | — |
| Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-∞) of MPA | Day 0 up to Week 52 | — |
| Part 1: Apparent Terminal Half-life (t1/2) of MPA | Day 0 up to Week 52 | — |
| Part 2: Time to Ovulation | Day 0 up to Week 78 | Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: AUC0-∞ of MPA | Day 0 up to Week 52 | — |
| Part 2: Apparent Terminal Half Life (t1/2) of MPA | Day 0 up to Week 52 | — |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 0 up to Week 78 | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Part 1: Time to Ovulation | Day 0 up to Week 78 | Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL. Time to ovulation was computed as the difference in days between detection of the first post-randomization elevated progesterone and the date of treatment initiation. Median time to ovulation was derived using Kaplan-Meier estimate. |
| Part 2: Cmax of MPA | Day 0 up to Week 52 | — |
| Part 2: Tmax of MPA | Day 0 up to Week 52 | — |
| Part 2: Observed Serum Drug Concentration at Day 210 (C210) of MPA | Day 0 up to Day 210 | — |
| Part 2: C182 of MPA | Day 0 up to Day 182 | — |
| Part 2: AUC0-182 of MPA | Day 0 up to Day 182 | — |
| Part 2: AUC0-210 of MPA | Day 0 up to Day 210 | — |
Countries
United States
Participant flow
Recruitment details
This was a 2-part study: Part 1 (Exploratory Pharmacokinetics \[PK\]) and Part 2 (Dose-range Finding).
Pre-assignment details
Due to suboptimal long-term stability and re-suspendability of the TV-46046 formulation, the decision was made not to initiate Part 2 of this clinical study, and to conduct a new dose-range finding study. Participants were planned to be assigned sequentially in 3 treatment groups in Part 1. The results of the first 2 groups did not warrant the evaluation of the intermediate concentration of TV-46046 and treatment group 3 was therefore not enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (TV-46046 - Undiluted) Participants received a single SC injection of undiluted TV-46046. | 6 |
| Group 2 (TV-46046 - Saline-diluted) Participants received a single SC injection of saline-diluted TV-46046. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued early due to personal decision | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Group 2 (TV-46046 - Saline-diluted) | Total | Group 1 (TV-46046 - Undiluted) |
|---|---|---|---|
| Age, Continuous | 34.2 years STANDARD_DEVIATION 5.08 | 31.8 years STANDARD_DEVIATION 5.01 | 29.5 years STANDARD_DEVIATION 4.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 | 1 / 6 |
Outcome results
Primary
Part 1: Apparent Terminal Half-life (t1/2) of MPA
Time frame: Day 0 up to Week 52
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Apparent Terminal Half-life (t1/2) of MPA | 82.87 days |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Apparent Terminal Half-life (t1/2) of MPA | 42.34 days |
90% CI: [0.23, 1.13]
Primary
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
Time frame: Day 0 up to Day 182
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 182 (AUC0-182) of MPA | 58.61 days*ng/mL |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 182 (AUC0-182) of MPA | 97.72 days*ng/mL |
90% CI: [1.33, 2.09]
Primary
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
Time frame: Day 0 up to Day 210
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 210 (AUC0-210) of MPA | 63.91 days*ng/mL |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 210 (AUC0-210) of MPA | 103.11 days*ng/mL |
90% CI: [1.3, 2.01]
Primary
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-∞) of MPA
Time frame: Day 0 up to Week 52
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-∞) of MPA | 94.56 days*ng/mL |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-∞) of MPA | 114.13 days*ng/mL |
90% CI: [1.04, 1.4]
Primary
Part 1: Maximum Observed Serum Concentration (Cmax) of MPA
Time frame: Day 0 up to Week 52
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Maximum Observed Serum Concentration (Cmax) of MPA | 0.53 ng/mL |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Maximum Observed Serum Concentration (Cmax) of MPA | 0.97 ng/mL |
90% CI: [1.44, 2.36]
Primary
Part 1: Observed Serum Drug Concentration at Day 182 (C182) of MPA
Time frame: Day 182
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Observed Serum Drug Concentration at Day 182 (C182) of MPA | 0.21 ng/mL |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Observed Serum Drug Concentration at Day 182 (C182) of MPA | 0.14 ng/mL |
90% CI: [0.33, 1.33]
Primary
Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1
'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Time frame: Day 1
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in their baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; body mass index (BMI) outside the eligible range; or use of drugs known to impact ovulation or pharmacokinetic (PK) of MPA (with the exception of selective cyclooxygenase-2 \[COX-2\] inhibitors that were taken for \<5 consecutive days).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1 | 0.36 nanograms (ng)/milliliter (mL) | Standard Deviation 0.13 |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1 | 0.67 nanograms (ng)/milliliter (mL) | Standard Deviation 0.22 |
Primary
Part 1: Serum MPA Concentration at Day 182
Time frame: Day 182
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Serum MPA Concentration at Day 182 | 0.22 ng/mL | Standard Deviation 0.08 |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Serum MPA Concentration at Day 182 | 0.17 ng/mL | Standard Deviation 0.1 |
Primary
Part 1: Serum MPA Concentration at Day 210
Time frame: Day 210
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Serum MPA Concentration at Day 210 | 0.20 ng/mL | Standard Deviation 0.05 |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Serum MPA Concentration at Day 210 | 0.12 ng/mL | Standard Deviation 0.09 |
Primary
Part 1: Serum MPA Concentration at Day 28
Time frame: Day 28
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Serum MPA Concentration at Day 28 | 0.36 ng/mL | Standard Deviation 0.07 |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Serum MPA Concentration at Day 28 | 0.69 ng/mL | Standard Deviation 0.25 |
Primary
Part 1: Serum MPA Concentration at Day 7
Time frame: Day 7
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Serum MPA Concentration at Day 7 | 0.37 ng/mL | Standard Deviation 0.1 |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Serum MPA Concentration at Day 7 | 0.70 ng/mL | Standard Deviation 0.22 |
Primary
Part 1: Serum MPA Concentration at Day 91
Time frame: Day 91
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Serum MPA Concentration at Day 91 | 0.41 ng/mL | Standard Deviation 0.13 |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Serum MPA Concentration at Day 91 | 0.62 ng/mL | Standard Deviation 0.09 |
Primary
Part 1: Time to Reach Cmax (Tmax) of MPA
Time frame: Day 0 up to Week 52
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Time to Reach Cmax (Tmax) of MPA | 9.49 days |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Time to Reach Cmax (Tmax) of MPA | 47.99 days |
Primary
Part 2: Time to Ovulation
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL.
Time frame: Day 0 up to Week 78
Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Day 0 up to Week 78
Population: Treated population included all screened participants who were enrolled and received a dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 6 Participants |
| Group 2 (TV-46046 - Saline-diluted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 6 Participants |
Secondary
Part 1: Time to Ovulation
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL. Time to ovulation was computed as the difference in days between detection of the first post-randomization elevated progesterone and the date of treatment initiation. Median time to ovulation was derived using Kaplan-Meier estimate.
Time frame: Day 0 up to Week 78
Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 (TV-46046 - Undiluted) | Part 1: Time to Ovulation | 328 days |
| Group 2 (TV-46046 - Saline-diluted) | Part 1: Time to Ovulation | 251 days |
p-value: 0.0073Log Rank
Secondary
Part 2: Apparent Terminal Half Life (t1/2) of MPA
Time frame: Day 0 up to Week 52
Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Secondary
Part 2: AUC0-182 of MPA
Time frame: Day 0 up to Day 182
Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Secondary
Part 2: AUC0-210 of MPA
Time frame: Day 0 up to Day 210
Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Secondary
Part 2: AUC0-∞ of MPA
Time frame: Day 0 up to Week 52
Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Secondary
Part 2: C182 of MPA
Time frame: Day 0 up to Day 182
Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Secondary
Part 2: Cmax of MPA
Time frame: Day 0 up to Week 52
Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Secondary
Part 2: Observed Serum Drug Concentration at Day 210 (C210) of MPA
Time frame: Day 0 up to Day 210
Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Secondary
Part 2: Tmax of MPA
Time frame: Day 0 up to Week 52
Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.