Pharmaverse

primary_outcomes	[object Object],[object Object]	→	[object Object],[object Object],[object Object]
secondary_outcomes	[object Object],[object Object],[object Object],[object Object]	→	[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CTGOV9/24/2026, 5:06:08 AM

Trial enrollment change

enrollment_count

128

→

160

CTGOV9/27/2026, 5:07:48 AM

Trial registered

record_exists

false

→

true

CTGOV10/1/2026, 5:06:27 AM

Trial eligibility change

eligibility_criteria

Inclusion Criteria: \- Adult patients aged 18-75 years Undergoing primary total ankle arthroplasty (TAA) Capable of completing questionnaires Capable of providing consent for enrollment Capable of using Suzetrigine times a day Capable of completing the follow-up visits Exclusion Criteria: \- BMI ≥ 50 kg/m² Pre-operative/current opioid consumption Prior history of ipsilateral ankle infection Severe hepatic impairment (Child-Pugh Class C) eGFR \< 30 ml/min Pregnant or lactating Heart failure or recent myocardial infarction Using strong CYP3A inhibitors (e.g., itraconazole) or strong/moderate CYP3A inducers (e.g., Rifampin) Women taking concomitant progestin-containing contraceptives other than levonorgestrel and norethindrone who are unwilling to use additional non-hormonal contraceptives (such as condoms) or alternative contraceptives during Suzetrigine treatment and for 28 days after discontinuation

→

Inclusion Criteria: * Adult patients aged 18-75 years * Undergoing primary total ankle arthroplasty (TAA) * Capable of completing study questionnaires * Capable of providing informed consent for enrollment * Capable of taking suzetrigine twice daily * Capable of completing the required follow-up visits Exclusion Criteria: * Declines to participate or discontinues participation during the study * Body mass index (BMI) ≥50 kg/m² * Preoperative or current opioid use * Prior history of ipsilateral ankle infection * Severe hepatic impairment (Child-Pugh Class C) * Estimated glomerular filtration rate (eGFR) \<30 mL/min * Pregnant or lactating * Heart failure or recent myocardial infarction * Requires non-antiplatelet anticoagulant therapy (e.g., heparin, warfarin \[Coumadin\], apixaban \[Eliquis\], or enoxaparin \[Lovenox\]) * Use of strong cytochrome P450 3A (CYP3A) inhibitors (e.g., itraconazole) or strong or moderate CYP3A inducers (e.g., rifampin) * Women taking concomitant progestin-containing contraceptives other than levonorgestrel or norethindrone who are unwilling to use an additional non-hormonal contraceptive method (e.g., condoms) or an alternative contraceptive during suzetrigine treatment and for 28 days after discontinuation

CTGOV10/1/2026, 5:06:27 AM

primary_outcomes	[object Object]	→	[object Object]
secondary_outcomes	[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]	→	[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CTGOV10/1/2026, 5:06:27 AM

overall_status

Not yet recruiting

→

Recruiting

CTGOV10/1/2026, 5:06:27 AM

location_count

0

→

1

CTGOV10/7/2026, 5:07:00 AM

location_count

0

→

3

CTGOV10/7/2026, 5:07:00 AM

overall_status

Not yet recruiting

→

Enrolling by invitation

CTGOV10/10/2026, 5:06:28 AM

overall_status

Active, not recruiting

→

Completed

CTGOV10/11/2026, 5:04:48 AM

Trial registered

record_exists

false

→

true

MARKET10/13/2026, 5:30:00 AM

Unusual move

MARKET10/14/2026, 5:30:00 AM

Unusual move

CTGOV10/15/2026, 5:06:07 AM

location_count

15

→

16

CTGOV10/16/2026, 5:05:56 AM

Trial results posted

results_first_posted	null	→	2026-10-15
adverse_events_module_present	false	→	true

CTGOV10/16/2026, 5:05:56 AM

Trial enrollment change

enrollment_count

70

→

67

CTGOV10/16/2026, 5:05:56 AM

primary_outcomes	[object Object],[object Object],[object Object]	→	[object Object],[object Object],[object Object]
secondary_outcomes	[object Object],[object Object]	→	[object Object],[object Object]

CTGOV10/16/2026, 5:07:57 AM

overall_status

Recruiting

→

Active, not recruiting

CTGOV10/16/2026, 5:07:57 AM

Trial enrollment change

enrollment_type	ESTIMATED	→	ACTUAL
enrollment_count	466	→	522

CTGOV10/16/2026, 5:07:57 AM

location_count

318

→

314

EDGAR10/19/2026, 5:30:00 AM

Insider transaction

EDGAR10/19/2026, 5:30:00 AM

Insider transaction

CTGOV10/20/2026, 5:05:07 AM

location_count

0

→

1

CTGOV10/20/2026, 5:05:07 AM

overall_status

Not yet recruiting

→

Recruiting

CTGOV10/20/2026, 5:05:24 AM

Trial eligibility change

eligibility_criteria

Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * A total body weight of more than (\>) 50 kg Key Exclusion Criteria: * History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * Any condition possibly affecting drug absorption Other protocol defined Inclusion/Exclusion criteria may apply.

→

Key Inclusion Criteria: * Parts A, B, C: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * A total body weight of more than (\>) 50 kg * Part D: * Confirmed diagnosis of CF Key Exclusion Criteria: * Parts A, B, C: * History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * Any condition possibly affecting drug absorption * Part D: * History of clinically significant cirrhosis with or without portal hypertension. Other protocol defined Inclusion/Exclusion criteria may apply.

CTGOV10/20/2026, 5:05:24 AM