Trial Outcomes & Findings for Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD) (NCT NCT01020487)

NCT ID: NCT01020487

Last Updated: 2018-07-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 47 participants
• Primary outcome timeframe: Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.
• Results posted on: 2018-07-02

Participant Flow

Part 1 was an open-label, single-dose study evaluating the pharmacokinetics of paricalcitol capsules in children with moderate to severe chronic kidney disease (CKD). Part 2 consisted of a double-blind, placebo-controlled study to evaluate safety and efficacy of paricalcitol and an open-label phase where all participants received paricalcitol.

Two participants enrolled in Part 2 after completing Part 1 of the study, hence the actual total number of enrolled participants is equal to 47.

Participant milestones

Measure	Part 1: Paricalcitol Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Placebo Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.	Part 2: Paricalcitol Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 1 STARTED	12	0	0
Part 1 COMPLETED	12	0	0
Part 1 NOT COMPLETED	0	0	0
Part 2 Double-blind Treatment Period STARTED	0	18	19
Part 2 Double-blind Treatment Period Received Treatment	0	18	18
Part 2 Double-blind Treatment Period COMPLETED	0	16	13
Part 2 Double-blind Treatment Period NOT COMPLETED	0	2	6
Part 2 Open-label Period STARTED	0	16	13
Part 2 Open-label Period COMPLETED	0	12	12
Part 2 Open-label Period NOT COMPLETED	0	4	1

Reasons for withdrawal

Measure	Part 1: Paricalcitol Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Placebo Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.	Part 2: Paricalcitol Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 2 Double-blind Treatment Period Adverse Event	0	2	1
Part 2 Double-blind Treatment Period Withdrawal by Subject	0	0	1
Part 2 Double-blind Treatment Period Required a Dose Reduction	0	0	3
Part 2 Double-blind Treatment Period Randomized in Error	0	0	1
Part 2 Open-label Period Adverse Event	0	4	1

Baseline Characteristics

Baseline measure data were analyzed separately for participants in Part 1 and Part 2.

Baseline characteristics by cohort

Measure	Part 1: Paricalcitol n=12 Participants Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Placebo n=18 Participants Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.	Part 2: Paricalcitol n=19 Participants Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.	Total n=49 Participants Total of all reporting groups
Age, Continuous Part 1	13.5 years STANDARD_DEVIATION 1.98 • n=12 Participants • Baseline measure data were analyzed separately for participants in Part 1 and Part 2.	—	—	13.5 years STANDARD_DEVIATION 1.98 • n=12 Participants • Baseline measure data were analyzed separately for participants in Part 1 and Part 2.
Age, Continuous Part 2	—	13.3 years STANDARD_DEVIATION 1.75 • n=18 Participants • Baseline measure data were analyzed separately for participants in Part 1 and Part 2.	13.9 years STANDARD_DEVIATION 1.81 • n=19 Participants • Baseline measure data were analyzed separately for participants in Part 1 and Part 2.	13.6 years STANDARD_DEVIATION 1.78 • n=37 Participants • Baseline measure data were analyzed separately for participants in Part 1 and Part 2.
Sex: Female, Male Female	3 Participants n=12 Participants	5 Participants n=18 Participants	6 Participants n=19 Participants	14 Participants n=49 Participants
Sex: Female, Male Male	9 Participants n=12 Participants	13 Participants n=18 Participants	13 Participants n=19 Participants	35 Participants n=49 Participants
Race/Ethnicity, Customized White	10 Participants n=12 Participants	17 Participants n=18 Participants	14 Participants n=19 Participants	41 Participants n=49 Participants
Race/Ethnicity, Customized Black	1 Participants n=12 Participants	0 Participants n=18 Participants	0 Participants n=19 Participants	1 Participants n=49 Participants
Race/Ethnicity, Customized Asian	0 Participants n=12 Participants	0 Participants n=18 Participants	4 Participants n=19 Participants	4 Participants n=49 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	1 Participants n=12 Participants	0 Participants n=18 Participants	0 Participants n=19 Participants	1 Participants n=49 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=12 Participants	0 Participants n=18 Participants	0 Participants n=19 Participants	0 Participants n=49 Participants
Race/Ethnicity, Customized Other	0 Participants n=12 Participants	1 Participants n=18 Participants	1 Participants n=19 Participants	2 Participants n=49 Participants
Chronic Kidney Disease Stage Stage 3	6 Participants n=12 Participants	11 Participants n=18 Participants	10 Participants n=19 Participants	27 Participants n=49 Participants
Chronic Kidney Disease Stage Stage 4	6 Participants n=12 Participants	7 Participants n=18 Participants	8 Participants n=19 Participants	21 Participants n=49 Participants
Chronic Kidney Disease Stage Missing	0 Participants n=12 Participants	0 Participants n=18 Participants	1 Participants n=19 Participants	1 Participants n=49 Participants

PRIMARY outcome

Timeframe: Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.

Population: All participants enrolled and administered paricalcitol for the pharmacokinetic (PK) period, Part 1

Outcome measures

Measure	Part 1: Paricalcitol n=12 Participants Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Paricalcitol Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax)	0.13 ng/mL Standard Deviation 0.052	—

PRIMARY outcome

Timeframe: Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.

Population: All participants enrolled and administered paricalcitol for the PK Portion, Part 1

Outcome measures

Measure	Part 1: Paricalcitol n=12 Participants Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Paricalcitol Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)	2.87 ng*hr/mL Standard Deviation 0.84	—

PRIMARY outcome

Timeframe: 12-week double-blind treatment period

Population: The Intent-To-Treat (ITT) Dataset, defined as the set of all randomized participants who took at least one dose of study drug.

The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage.

Outcome measures

Measure	Part 1: Paricalcitol n=18 Participants Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Paricalcitol n=18 Participants Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH	0 percentage of participants	27.8 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to treat dataset

The Kidney Disease Outcomes Quality Initiatives (KDOQI) Pediatric Subcommittee on Practice Guidelines for Bone Metabolism and Disease in Children with CKD target range for intact parathyroid hormone (iPTH) is as follows::

CKD Stage 3: 35 - 69 pg/mL; CKD Stage 4: 70 - 110 pg/mL.

Outcome measures

Measure	Part 1: Paricalcitol n=18 Participants Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Paricalcitol n=18 Participants Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges	11.1 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8 and 12

Population: Intent to treat dataset with available data at each time point

Outcome measures

Measure	Part 1: Paricalcitol n=18 Participants Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Paricalcitol n=18 Participants Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 2: Change From Baseline in iPTH to Each Post-baseline Visit Week 12	71.47 pg/mL Standard Error 17.661	-17.05 pg/mL Standard Error 19.186
Part 2: Change From Baseline in iPTH to Each Post-baseline Visit Week 2	50.39 pg/mL Standard Error 15.186	-12.16 pg/mL Standard Error 14.695
Part 2: Change From Baseline in iPTH to Each Post-baseline Visit Week 4	57.16 pg/mL Standard Error 20.813	-11.27 pg/mL Standard Error 22.117
Part 2: Change From Baseline in iPTH to Each Post-baseline Visit Week 8	57.31 pg/mL Standard Error 22.099	-12.79 pg/mL Standard Error 24.814

SECONDARY outcome

Timeframe: Week 12

Population: Intent to treat dataset

KDOQI recommends serum calcium is maintained within age appropriate normal ranges:

Age 6 - 12: 9.4 - 10.2 mg/dL (2.35 - 2.55 mmol/L); Age 13 - 20: 8.8 - 10.2 mg/dL (2.20 - 2.55 mmol/L).

Outcome measures

Measure	Part 1: Paricalcitol n=18 Participants Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Paricalcitol n=18 Participants Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges	94.4 percentage of participants	83.3 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Intent to treat dataset

The KDOQI target ranges of serum phosphorus are to maintain at or above age appropriate lower limits and no higher than the age-appropriate upper limits:

Age 6 - 12: 3.6 - 5.8 mg/dL (1.16 - 1.87 mmol/L); Age 13 - 20: 2.3 - 4.5 mg/dL (0.74 - 1.45 mmol/L).

Outcome measures

Measure	Part 1: Paricalcitol n=18 Participants Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Paricalcitol n=18 Participants Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges	72.2 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 8 and 12

Population: Intent-to-treat dataset with available Baseline data, and available data at each time point

The mean change from Baseline in FMV UACR on a log scale to each post baseline visit.

Outcome measures

Measure	Part 1: Paricalcitol n=15 Participants Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Paricalcitol n=16 Participants Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR) Week 4	-0.12 mg/g Standard Error 0.126	-0.13 mg/g Standard Error 0.132
Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR) Week 8	-0.13 mg/g Standard Error 0.141	-0.01 mg/g Standard Error 0.155
Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR) Week 12	-0.08 mg/g Standard Error 0.259	0.22 mg/g Standard Error 0.292

Adverse Events

Part 1: Paricalcitol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2: Placebo

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Part 2: Paricalcitol

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 2: Placebo/Paricalcitol

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 2: Paricalcitol/Paricalcitol

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: Paricalcitol n=12 participants at risk Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Placebo n=18 participants at risk Participants received placebo capsules three times a week for 12 weeks during the double-blind treatment phase.	Part 2: Paricalcitol n=18 participants at risk Participants received paricalcitol three times a week (TIW) for 12 weeks during the double-blind treatment period. The initial dose of paricalcitol was 1 µg TIW. Doses could be adjusted based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) levels.	Part 2: Placebo/Paricalcitol n=16 participants at risk Participants who received placebo in the double-blind treatment phase received open-label paricalcitol at an initial dose of 1 µg three times a week in the open- label treatment phase (Weeks 12-24). Doses could be adjusted based on chemistry evaluations to target KDOQI levels.	Part 2: Paricalcitol/Paricalcitol n=13 participants at risk Participants who received paricalcitol during the double-blind treatment period continued to receive paricalcitol three times a week during the open-label period (Weeks 12-24).
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations VIRAL INFECTION	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Investigations BLOOD CREATININE INCREASED	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Psychiatric disorders HOMICIDAL IDEATION	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Renal and urinary disorders RENAL FAILURE CHRONIC	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Renal and urinary disorders RENAL IMPAIRMENT	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Vascular disorders HYPERTENSIVE CRISIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).

Other adverse events

Measure	Part 1: Paricalcitol n=12 participants at risk Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.	Part 2: Placebo n=18 participants at risk Participants received placebo capsules three times a week for 12 weeks during the double-blind treatment phase.	Part 2: Paricalcitol n=18 participants at risk Participants received paricalcitol three times a week (TIW) for 12 weeks during the double-blind treatment period. The initial dose of paricalcitol was 1 µg TIW. Doses could be adjusted based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) levels.	Part 2: Placebo/Paricalcitol n=16 participants at risk Participants who received placebo in the double-blind treatment phase received open-label paricalcitol at an initial dose of 1 µg three times a week in the open- label treatment phase (Weeks 12-24). Doses could be adjusted based on chemistry evaluations to target KDOQI levels.	Part 2: Paricalcitol/Paricalcitol n=13 participants at risk Participants who received paricalcitol during the double-blind treatment period continued to receive paricalcitol three times a week during the open-label period (Weeks 12-24).
Blood and lymphatic system disorders ANAEMIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Ear and labyrinth disorders EAR PAIN	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	12.5% 2/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Endocrine disorders HYPERPARATHYROIDISM	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Gastrointestinal disorders ABDOMINAL PAIN	8.3% 1/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Gastrointestinal disorders CONSTIPATION	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Gastrointestinal disorders DIARRHOEA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Gastrointestinal disorders GASTRITIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Gastrointestinal disorders NAUSEA	8.3% 1/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Gastrointestinal disorders TOOTHACHE	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Gastrointestinal disorders VOMITING	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
General disorders FEELING HOT	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
General disorders OEDEMA PERIPHERAL	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
General disorders PYREXIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations ACUTE SINUSITIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations CONJUNCTIVITIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations GASTROENTERITIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations HERPES SIMPLEX	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations IMPETIGO	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations INFLUENZA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations NASOPHARYNGITIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	11.1% 2/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	15.4% 2/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations OTITIS MEDIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations PARONYCHIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations PHARYNGITIS STREPTOCOCCAL	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	12.5% 2/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations RHINITIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	16.7% 3/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations TOOTH INFECTION	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	12.5% 2/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Infections and infestations VIRAL INFECTION	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	11.1% 2/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Injury, poisoning and procedural complications INJURY	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Investigations BLOOD POTASSIUM INCREASED	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Investigations VITAMIN D DECREASED	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Metabolism and nutrition disorders ACIDOSIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	11.1% 2/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	18.8% 3/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	18.8% 3/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	12.5% 2/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Metabolism and nutrition disorders METABOLIC ACIDOSIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Nervous system disorders DIZZINESS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Nervous system disorders HEADACHE	8.3% 1/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Nervous system disorders SYNCOPE	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Psychiatric disorders THINKING ABNORMAL	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Renal and urinary disorders MICTURITION URGENCY	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Renal and urinary disorders PROTEINURIA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Renal and urinary disorders RENAL FAILURE CHRONIC	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Respiratory, thoracic and mediastinal disorders WHEEZING	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Skin and subcutaneous tissue disorders ACNE	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Skin and subcutaneous tissue disorders COLD SWEAT	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	7.7% 1/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Skin and subcutaneous tissue disorders INGROWING NAIL	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Skin and subcutaneous tissue disorders RASH	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	6.2% 1/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Vascular disorders HYPERTENSION	0.00% 0/12 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	5.6% 1/18 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/16 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).	0.00% 0/13 • Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER