A Study of IW-6463 in Healthy Volunteers

NCT03856827 | Completed Phase 1 FDA Drug

• 2 other identifiers: C6463-101CY6463
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Other

Outcome Measures

Primary Outcomes (4)

• After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) in the IW-6463 dose-level cohorts vs the (pooled) placebo group.

  Up to 9 days

• After multiple ascending doses, number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the (pooled) placebo group.

  Up to 32 days

• After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period

  Up to 28 days

• Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions

  Up to 21 days

Study Arms (2)

IW-6463

EXPERIMENTAL

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

Drug: IW-6463

Placebo

PLACEBO COMPARATOR

Matching placebo tablets administered orally

Drug: Matching Placebo

Interventions

IW-6463 DRUG

IW-6463 Tablet

Also known as: CY6463, zagociguat

IW-6463

Matching Placebo DRUG

Matching Placebo Tablet

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any active or unstable clinically significant medical condition
• Use of any prescribed or non-prescribed medication

Sponsors & Collaborators

• Tisento Therapeutics: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, 2333 CL, Netherlands

Location

Study Officials

• Chad Glasser, PharmD

  Cyclerion Therapeutics, Inc

  STUDY DIRECTOR

• Geert J Groeneveld, MSc

  Centre for Human Drug Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 27, 2019
• Study Start: February 6, 2019
• Primary Completion: October 22, 2019
• Study Completion: October 22, 2019
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

NL (1)