Trial Outcomes & Findings for CX-8998 for Absence Seizures (NCT NCT03406702)

NCT ID: NCT03406702

Last Updated: 2022-09-08

Results Overview

Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 7 participants
• Primary outcome timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.
• Results posted on: 2022-09-08

Participant Flow

Participants underwent a screening period of up to 4 weeks.

Participant milestones

Measure	CX-8998 Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	CX-8998 Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).
Overall Study Missed Day 27 Dosing	1

Baseline Characteristics

CX-8998 for Absence Seizures

Baseline characteristics by cohort

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).
Age, Continuous	31.3 years STANDARD_DEVIATION 8.67 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: QTcF was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Fridericia's Correction Formula (QTCF) is a formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, permitting comparison of the QT interval across a range of rates.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF)	3.50 msec Standard Deviation 10.213	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical alanine aminotransferase serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in alanine aminotransferase serum chemistry concentration.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Alanine Aminotransferase Serum Chemistry Concentration	17.29 U/L Standard Deviation 33.604	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical albumin serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in albumin serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Albumin Serum Chemistry Concentration	-0.29 g/L Standard Deviation 4.152	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical albumin/globulin serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in albumin/globulin serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Albumin/Globulin Serum Chemistry Concentration	-0.15 ratio Standard Deviation 0.212	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical alkaline phosphatase serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in alkaline phosphatase serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Alkaline Phosphatase Serum Chemistry Concentration	3.14 U/L Standard Deviation 10.399	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical aspartate aminotransferase serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in aspartate aminotransferase serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Aspartate Aminotransferase Serum Chemistry Concentration	27.71 U/L Standard Deviation 60.810	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Clinical BUN/Creatinine serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory assessment in BUN/Creatinine serum chemistry.

Outcome measures

Measure	CX-8998 n=1 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline Clinical Blood Urea Nitrogen/Creatinine Serum Chemistry Concentration	12.70 ratio Standard Deviation NA Only 1 participant was analyzed so standard deviation could not be calculated for this assessment.	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical bilirubin serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory assessment in bilirubin serum chemistry.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Bilirubin Serum Chemistry Concentration	-0.55 umol/L Standard Deviation 2.577	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical blood urea nitrogen serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in blood urea nitrogen serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Blood Urea Nitrogen Serum Chemistry Concentration	0.23 umol/L Standard Deviation 1.254	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical carbon dioxide serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in carbon dioxide serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Carbon Dioxide Serum Chemistry Concentration	0.43 nmol/L Standard Deviation 2.936	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical chloride serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in chloride serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Chloride Serum Chemistry Concentration	-0.86 nmol/L Standard Deviation 3.716	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical calcium serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in calcium serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Calcium Serum Chemistry Concentration	-0.01 nmol/L Standard Deviation 0.109	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical cholesterol serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in cholesterol serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Cholesterol Serum Chemistry Concentration	0.60 nmol/L Standard Deviation 0.895	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Clinical cholesterol/HDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory assessment in cholesterol/HDL-cholesterol serum chemistry.

Outcome measures

Measure	CX-8998 n=1 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline Clinical Cholesterol/HDL-Cholesterol Serum Chemistry Concentration	2.40 ratio Standard Deviation NA Only 1 participant was analyzed so standard deviation could not be calculated for this assessment.	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical creatine kinase serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in creatine kinase serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Creatine Kinase Serum Chemistry Concentration	1174.86 U/L Standard Deviation 3110.151	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical creatinine serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in creatinine serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Creatinine Serum Chemistry Concentration	-4.14 umol/L Standard Deviation 9.737	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical globulin serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in globulin serum chemistry.

Outcome measures

Measure	CX-8998 n=2 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Globulin Serum Chemistry Concentration	0.15 g/dL Standard Deviation 0.071	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: The clinical glomerular filtration rate adjusted for BSA serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory assessment in glomerular filtration rate adjusted for BSA chemistry.

Outcome measures

Measure	CX-8998 n=1 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline Clinical Glomerular Filtration Rate (GFR) Adjusted for Body Surface Area (BSA) Serum Chemistry Concentration	1.80 mL/sec/1.73m^2 Standard Deviation NA Only 1 participant was analyzed so standard deviation could not be calculated for this assessment.	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical GFR serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in GFR serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Estimated Glomerular Filtration Rate (GFR) Serum Chemistry Concentration	-5.82 mL/sec/1.73m^2 Standard Deviation 9.691	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical glucose serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in glucose serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Glucose Serum Chemistry Concentration	-0.14 nmol/L Standard Deviation 0.526	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Clinical HDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory assessment in HDL cholesterol serum chemistry.

Outcome measures

Measure	CX-8998 n=1 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline Clinical HDL Cholesterol Serum Chemistry Concentration	1.35 nmol/L Standard Deviation NA Only 1 participant was analyzed so standard deviation could not be calculated for this assessment.	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Clinical LDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory assessment in LDL cholesterol serum chemistry.

Outcome measures

Measure	CX-8998 n=1 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline Clinical LDL Cholesterol Serum Chemistry Concentration	1.50 nmol/L Standard Deviation NA Only 1 participant was analyzed so standard deviation could not be calculated for this assessment.	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical lactate dehydrogenase serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in lactate dehydrogenase serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Lactate Dehydrogenase Serum Chemistry Concentration	53.86 U/L Standard Deviation 98.104	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical magnesium serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in magnesium serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Magnesium Serum Chemistry Concentration	-0.02 nmol/L Standard Deviation 0.077	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Clinical LDL-cholesterol serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory assessment in non-HDL cholesterol serum chemistry.

Outcome measures

Measure	CX-8998 n=1 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline Clinical Non-HDL Cholesterol Serum Chemistry Concentration	1.84 nmol/L Standard Deviation NA Only 1 participant was analyzed so standard deviation could not be calculated for this assessment.	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical phosphate serum chemistry was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory assessment in phosphate serum chemistry.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Phosphate Serum Chemistry Concentration	0.09 nmol/L Standard Deviation 0.163	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical potassium serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in potassium serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Potassium Serum Chemistry Concentration	0.34 nmol/L Standard Deviation 0.532	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical protein serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in protein serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Protein Serum Chemistry Concentration	0.29 g/L Standard Deviation 3.352	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical sodium serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in sodium serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Sodium Serum Chemistry Concentration	-0.57 nmol/L Standard Deviation 1.902	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical triglycerides serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in triglycerides serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Triglycerides Serum Chemistry Concentration	0.17 nmol/L Standard Deviation 0.659	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical urate serum chemistry was assessed using the safety population.

Clinical safety laboratory assessment in urate serum chemistry.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Clinical Urate Serum Chemistry Concentration	8.71 umol/L Standard Deviation 48.555	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical basophils were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory basophils hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Basophils Hematology Assessment	0.02 cellsx10E9/L Standard Deviation 0.029	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical basophils/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory basophils/leukocytes hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Basophils/Leukocytes Hematology Assessment	0.00 ratio Standard Deviation 0.004	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical eosinophils were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory eosinophils hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Eosinophils Hematology Assessment	0.02 cellsx10E9/L Standard Deviation 0.042	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical eosinophils/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory eosinophils/leukocytes hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Eosinophils/Leukocytes Hematology Assessment	0.00 ratio Standard Deviation 0.007	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical mean corpuscular HGB concentration was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory mean corpuscular HGB concentration hematology assessment.

Outcome measures

Measure	CX-8998 n=2 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Concentration Hematology Assessment	0.00 nmol/L Standard Deviation 1.230	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical mean corpuscular HGB was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory mean corpuscular HGB hematology assessment.

Outcome measures

Measure	CX-8998 n=2 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Mean Corpuscular Hemoglobin (HGB) Hematology Assessment	-0.04 fmol Standard Deviation 0.049	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical mean corpuscular volume was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory mean corpuscular volume hematology assessment.

Outcome measures

Measure	CX-8998 n=2 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Mean Corpuscular Volume Hematology Assessment	-1.00 fL Standard Deviation 2.828	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical erythrocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory erythrocytes hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Erythrocytes Hematology Assessment	-0.02 cellsx10E12/L Standard Deviation 0.194	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical erythrocytes distribution width was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory erythrocytes distribution width hematology assessment.

Outcome measures

Measure	CX-8998 n=2 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Erythrocytes Distribution Width Hematology Assessment	0.00 ratio Standard Deviation 0.000	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical hematocrit was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory hematocrit hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Hematocrit Hematology Assessment	0.00 ratio Standard Deviation 0.015	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Clinical hemoglobin was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory hemaglobin hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Hemaglobin Hematology Assessment	1.17 g/L Standard Deviation 6.555	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory leukocytes hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Leukocytes Hematology Assessment	0.25 cellsx10E9/L Standard Deviation 2.228	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Lymphocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory lymphocytes hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Lymphocytes Hematology Assessment	-0.17 cellsx10E9/L Standard Deviation 0.452	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Lymphocytes/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory lymphocytes/leukocytes hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Lymphocytes/Leukocytes Hematology Assessment	-0.02 ratio Standard Deviation 0.045	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Mean platelet volume was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory mean platelet volume hematology assessment.

Outcome measures

Measure	CX-8998 n=2 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Mean Platelet Volume Hematology Assessment	0.65 fL Standard Deviation 1.202	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Monocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory monocytes hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Monocytes Hematology Assessment	0.01 cellsx10E9/L Standard Deviation 0.067	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Monocytes/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory monocytes/leukocytes hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Monocytes/Leukocytes Hematology Assessment	0.00 ratio Standard Deviation 0.021	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Neutrophils were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory neutrophils hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Neutrophils Hematology Assessment	0.41 cellsx10E9/L Standard Deviation 1.911	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Neutrophils/leukocytes were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory neutrophils/leukocytes hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Neutrophils/Leukocytes Hematology Assessment	0.02 ratio Standard Deviation 0.063	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Platelets were assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Clinical safety laboratory platelets hematology assessment.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Platelets Hematology Assessment	10.67 cellsx10E9/L Standard Deviation 38.645	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Bacteria urinalysis was assessed using the safety population.

Clinical safety laboratory bacteria urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Bacteria Urinalysis Assessment Baseline (Not seen)	1 Participants	—	—	—	—
Baseline to End of Treatment in Bacteria Urinalysis Assessment End of Treatment (Few)	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Urine bilirubin was assessed using the safety population.

Clinical safety laboratory urine bilirubin urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment Baseline (Negative)	4 Participants	—	—	—	—
Baseline to End of Treatment in Urine Bilirubin Urinalysis Assessment End of Treatment (Negative)	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Epithelial cells were assessed using the safety population.

Clinical safety laboratory epithelial cells urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-10 epithelial cells/high power field (hpf). A worse outcome is >10 epithelial cells.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment Baseline (0-10)	1 Participants	—	—	—	—
Baseline to End of Treatment in Epithelial Cells Urinalysis Assessment End of Treatment (>10)	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Urine erythrocytes were assessed using the safety population.

Clinical safety laboratory urine erythrocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-2 erythrocytes/high power field (hpf). A better outcome is 0 or "none seen."

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment Baseline (0-2)	1 Participants	—	—	—	—
Baseline to End of Treatment in Urine Erythrocytes Urinalysis Assessment End of Treatment (None seen)	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Urine glucose were assessed using the safety population.

Clinical safety laboratory urine glucose urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Urine Glucose Urinalysis Assessment Baseline (Negative)	4 Participants	—	—	—	—
Baseline to End of Treatment in Urine Glucose Urinalysis Assessment End of Treatment (Negative)	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Ketones were assessed using the safety population.

Clinical safety laboratory ketones urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Ketones Urinalysis Assessment Baseline (Negative)	3 Participants	—	—	—	—
Baseline to End of Treatment in Ketones Urinalysis Assessment Baseline (Trace)	1 Participants	—	—	—	—
Baseline to End of Treatment in Ketones Urinalysis Assessment End of Treatment (Negative)	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Leukocyte esterase was assessed using the safety population.

Clinical safety laboratory leukocyte esterase urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment Baseline (Negative)	4 Participants	—	—	—	—
Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment End of Treatment (2+)	1 Participants	—	—	—	—
Baseline to End of Treatment in Leukocyte Esterase Urinalysis Assessment End of Treatment (Negative)	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Urine leukocytes were assessed using the safety population.

Clinical safety laboratory urine leukocytes urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal range is 0-5 leukocytes/high power field (hpf). An abnormal assessment or worse outcome is >5 leukocytes/hpf (i.e., 11-30).

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment Baseline (0-5)	1 Participants	—	—	—	—
Baseline to End of Treatment in Urine Leukocytes Urinalysis Assessment End of Treatment (11-30)	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Mucous threads were assessed using the safety population.

Clinical safety laboratory mucous threads urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Mucous Threads Urinalysis Assessment Baseline (Present)	1 Participants	—	—	—	—
Baseline to End of Treatment in Mucous Threads Urinalysis Assessment End of Treatment (Present)	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Nitrite was assessed using the safety population.

Clinical safety laboratory nitrite urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Nitrite Urinalysis Assessment Baseline (Negative)	4 Participants	—	—	—	—
Baseline to End of Treatment in Nitrite Urinalysis Assessment End of Treatment (Negative)	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Occult blood was assessed using the safety population.

Clinical safety laboratory occult blood urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is "negative." An abnormal assessment or worse outcome is a positive assessment (i.e., 2+).

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Occult Blood Urinalysis Assessment Baseline (2+)	1 Participants	—	—	—	—
Baseline to End of Treatment in Occult Blood Urinalysis Assessment Baseline (Negative)	3 Participants	—	—	—	—
Baseline to End of Treatment in Occult Blood Urinalysis Assessment End of Treatment (Negative)	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Protein was assessed using the safety population.

Clinical safety laboratory protein urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Protein Urinalysis Assessment Baseline (Negative)	4 Participants	—	—	—	—
Baseline to End of Treatment in Protein Urinalysis Assessment End of Treatment (Negative)	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Specific gravity was assessed using the safety population.

Clinical safety laboratory specific gravity urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed. A normal assessment or better outcome is 1.005-1.030. An abnormal assessment or worse outcome is a value outside of this range.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment Baseline (1.025)	1 Participants	—	—	—	—
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment Baseline (1.029)	1 Participants	—	—	—	—
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment End of Treatment (1.024)	1 Participants	—	—	—	—
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment End of Treatment (1.026)	1 Participants	—	—	—	—
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment End of Treatment (1.023)	1 Participants	—	—	—	—
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment Baseline (1.015)	1 Participants	—	—	—	—
Baseline to End of Treatment in Specific Gravity Urinalysis Assessment Baseline (1.019)	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Specimen appearance was assessed using the safety population.

Clinical safety laboratory specimen appearance urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment Baseline (Clear)	4 Participants	—	—	—	—
Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment End of Treatment (Clear)	1 Participants	—	—	—	—
Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment End of Treatment (Cloudy)	1 Participants	—	—	—	—
Baseline to End of Treatment in Specimen Appearance Urinalysis Assessment End of Treatment (Turbid)	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Urobilinogen was assessed using the safety population.

Clinical safety laboratory urobilinogen urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Urobilinogen Urinalysis Assessment	0.00 nmol/L Standard Deviation 0.000	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: pH was assessed using the safety population.

Clinical safety laboratory pH urinalysis assessment. Shifts from baseline to normal/abnormal status were assessed.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in pH Urinalysis Assessment Baseline (5)	1 Participants	—	—	—	—
Baseline to End of Treatment in pH Urinalysis Assessment Baseline (6)	1 Participants	—	—	—	—
Baseline to End of Treatment in pH Urinalysis Assessment Baseline (6.6)	1 Participants	—	—	—	—
Baseline to End of Treatment in pH Urinalysis Assessment Baseline (7)	1 Participants	—	—	—	—
Baseline to End of Treatment in pH Urinalysis Assessment End of Treatment (5)	1 Participants	—	—	—	—
Baseline to End of Treatment in pH Urinalysis Assessment End of Treatment (5.5)	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment, or up to 4 weeks post-dose.

Population: Urine color was assessed using the safety population.

Clinical safety laboratory urine color urinalysis assessment.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline to End of Treatment in Urine Color Urinalysis Assessment Baseline (Yellow)	4 Participants	—	—	—	—
Baseline to End of Treatment in Urine Color Urinalysis Assessment End of Treatment (Yellow)	2 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks.

Population: Participants who did not complete the study was assessed using the safety population. The number of participants analyzed varied as participation declined over time.

Treatment-emergent adverse events are all adverse events occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period as assessed by CTCAE v4.0.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) n=5 Participants Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) n=6 Participants Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) n=6 Participants Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) n=6 Participants Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Number (%) of Participants Who Did Not Complete The Study Due to Treatment-Emergent Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Day 26 post-dose, or up to 1 year 3 weeks.

Population: Participants with adverse events of special interest were assessed using the safety population. The number of participants analyzed varied as participation declined over time.

An adverse event of special interest is a serious adverse event as defined in Outcome 6. This includes, however is not limited to, increased seizure frequency, new seizure types, worsening of EEG parameters, systemic adverse events based on safety profile as assessed by CTCAE v4.0.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) n=5 Participants Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) n=6 Participants Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) n=6 Participants Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) n=6 Participants Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Number (%) of Participants With Adverse Events of Special Interest Any Event	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number (%) of Participants With Adverse Events of Special Interest Seizure	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: Respiration rate was assessed using the safety population.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Respiration Rate	0.29 breaths/min Standard Deviation 1.380	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: Temperature was assessed using the safety population.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Temperature	-0.01 celsius Standard Deviation 0.430	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1)

Population: Weight was assessed using the safety population.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Baseline Weight	82.19 kg Standard Deviation 15.963	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: Pulse was assessed using the safety population.

The change from baseline to end of treatment in participants' pulses was assessed. The changes in recumbent pulse, standing pulse, and the change from recumbent to standing pulse are reported. Change from recumbent to standing pulse was measured by the difference in recumbent pulse change and standing pulse change.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Pulse Standing	-5.57 bpm Standard Deviation 6.973	—	—	—	—
Change From Baseline to End of Treatment in Pulse Recumbent	-9.71 bpm Standard Deviation 8.036	—	—	—	—
Change From Baseline to End of Treatment in Pulse Change from Recumbent to Standing	4.14 bpm Standard Deviation 5.956	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: Systolic blood pressure was assessed using the safety population.

The change from baseline to end of treatment in participants' systolic blood pressure (sbp) was assessed. The changes in recumbent sbp, standing sbp, and the change from recumbent to standing sbp are reported. Change from recumbent to standing sbp was measured by the difference in recumbent sbp change and standing sbp change.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Systolic Blood Pressure Recumbent	-3.29 mmHg Standard Deviation 14.338	—	—	—	—
Change From Baseline to End of Treatment in Systolic Blood Pressure Standing	-2.86 mmHg Standard Deviation 12.103	—	—	—	—
Change From Baseline to End of Treatment in Systolic Blood Pressure Change from Recumbent to Standing	0.43 mmHg Standard Deviation 4.962	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: Diastolic blood pressure was assessed using the safety population.

The change from baseline to end of treatment in participants' diastolic blood pressure (dbp) was assessed. The changes in recumbent dbp, standing dbp, and the change from recumbent to standing dbp are reported. Change from recumbent to standing dbp was measured by the difference in recumbent dbp change and standing dbp change.

Outcome measures

Measure	CX-8998 n=7 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Diastolic Blood Pressure Recumbent	-8.14 mmHg Standard Deviation 14.916	—	—	—	—
Change From Baseline to End of Treatment in Diastolic Blood Pressure Standing	1.86 mmHg Standard Deviation 7.267	—	—	—	—
Change From Baseline to End of Treatment in Diastolic Blood Pressure Change from Recumbent to Standing	10.00 mmHg Standard Deviation 8.737	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: QT was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in QT Interval	-2.67 msec Standard Deviation 12.801	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: QRS interval was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in QRS Interval	-1.50 msec Standard Deviation 2.811	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: PR interval was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in PR Interval	-0.17 msec Standard Deviation 7.026	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) to end of treatment 1-2 hours post-dose, up to 4 weeks post-dose.

Population: Heart rate was assessed using the safety population. The number of participants varied due to the lack of completion of assessments.

Outcome measures

Measure	CX-8998 n=6 Participants Participants underwent a 4-week dose-titration treatment period up to a dose of 10 mg twice daily (BID) of suvecaltamide in the following schedule: Days 1 to 2: 2 mg BID (4 mg/d); Days 3 to 8: 4 mg BID (8 mg/d); Days 9 to 14: 6 mg BID (12 mg/d); Days 15 to 20: 8 mg BID (16 mg/d); Days 21 to 26: 10 mg BID (20 mg/d).	CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2- 2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3- 2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Change From Baseline to End of Treatment in Heart Rate	3.67 beats/min Standard Deviation 13.866	—	—	—	—

Adverse Events

CX-8998 Days 1 - 2 (4 mg/d)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

CX-8998 Days 3 - 8 (8 mg/d)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

CX-8998 Days 9 - 14 (12 mg/d)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CX-8998 Days 15 - 20 (16 mg/d)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

CX-8998 Days 21 - 27 (20 mg/d)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CX-8998 Days 1 - 2 (4 mg/d) n=7 participants at risk Participants were administered suvecaltamide orally 2mg capsules twice daily (4 mg/d) on Days 1 to 2.	CX-8998 Days 3 - 8 (8 mg/d) n=5 participants at risk Participants were administered suvecaltamide orally 2-2mg capsules twice daily (8 mg/d) on Days 3 to 8.	CX-8998 Days 9 - 14 (12 mg/d) n=6 participants at risk Participants were administered suvecaltamide orally 3-2mg capsules twice daily (12 mg/d) on Days 9 to 14.	CX-8998 Days 15 - 20 (16 mg/d) n=6 participants at risk Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20.	CX-8998 Days 21 - 27 (20 mg/d) n=6 participants at risk Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27.
Cardiac disorders Palpitations	0.00% 0/7 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/5 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	16.7% 1/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
Eye disorders Visual impairment	14.3% 1/7 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/5 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
Gastrointestinal disorders Dry mouth	0.00% 0/7 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	20.0% 1/5 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
Gastrointestinal disorders Nausea	0.00% 0/7 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	20.0% 1/5 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
General disorders Sluggishness	0.00% 0/7 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/5 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	16.7% 1/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
Nervous system disorders Seizure	14.3% 1/7 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/5 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	16.7% 1/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
Nervous system disorders Headache	14.3% 1/7 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/5 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
Nervous system disorders Lethargy	0.00% 0/7 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/5 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	16.7% 1/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
Psychiatric disorders Euphoric mood	0.00% 0/7 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	20.0% 1/5 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.	0.00% 0/6 • Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks. Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.

Additional Information

Clinical Trial Disclosure & Transparency

Jazz Pharmaceuticals

Phone: 215-832-3750

Email: ClinicalTrialDisclosure@JazzPharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place