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OpenTrials
Completed

NCT Number: NCT03856827

A Study of IW-6463 in Healthy Volunteers

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)

Completed

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Key information

Conditions

Other

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, 2333 CL, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IW-6463

Drug

IW-6463 Tablet

Other names: CY6463, zagociguat

Matching Placebo

Drug

Matching Placebo Tablet

Primary outcomes

  1. 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.

    Time frame: Up to 9 days

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

    Time frame: Up to 32 days

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

    Time frame: Up to 28 days

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

    Time frame: Up to 21 days

Sponsors and collaborators

Lead sponsor

Tisento Therapeutics

Industry

Registry information

Official study title

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of IW-6463 When Administered to Healthy Volunteers as Single Ascending Doses, as Multiple Ascending Doses, and Under Fed Versus Fasting Conditions

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2019
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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