A Study of IW-6463 in Healthy Volunteers

Tisento Therapeutics

Status and phase: Completed; Phase 1

Conditions: Other

Treatments: Drug: IW-6463; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03856827

CY6463 (Other Identifier)

C6463-101

Details and patient eligibility

About

Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects

Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects

Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)

Enrollment: 110 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is an ambulatory adult between 18 and 64 years old at the screening visit with the exception of the elderly cohort, who must be 65 years or older at the screening visit.
• Subject is in good health and has no clinically significant findings on physical examination
• Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 3 months after the final dose of study drug
• Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 3 months after the final dose of study drug
• Other inclusion criteria per protocol

Exclusion criteria

• Any active or unstable clinically significant medical condition
• Use of any prescribed or non-prescribed medication
• Other exclusion criteria per protocol

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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110 participants in 2 patient groups, including a placebo group

IW-6463

Experimental group

Description:

IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food

Treatment:

Drug: IW-6463

Placebo

Placebo Comparator group

Description:

Matching placebo tablets administered orally

Treatment:

Drug: Matching Placebo