A Study of IW-6463 in Healthy Volunteers

Other Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856827
• Other study ID #: C6463-101
• Secondary ID: CY6463
• Status: Completed
• Phase: Phase 1
• Start date: February 6, 2019
• Est. completion date: October 22, 2019

Study information

• Verified date: October 2023
• Source: Tisento Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 22, 2019
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Other

Intervention

Drug:
• IW-6463
IW-6463 Tablet
• Matching Placebo
Matching Placebo Tablet

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Tisento Therapeutics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period		Up to 28 days
Primary	Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions		Up to 21 days