A Study of IW-6463 in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT03856827 |
Recruitment Status :
Completed
First Posted : February 27, 2019
Last Update Posted : November 20, 2020
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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)
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Other | Drug: IW-6463 Drug: Matching Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | February 6, 2019 |
Actual Primary Completion Date : | October 22, 2019 |
Actual Study Completion Date : | October 22, 2019 |
Arm | Intervention/treatment |
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Experimental: IW-6463
IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food
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Drug: IW-6463
IW-6463 Tablet |
Placebo Comparator: Placebo
Matching placebo tablets administered orally
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Drug: Matching Placebo
Matching Placebo Tablet |
- 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 ]
- 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 ]
- After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period [ Time Frame: Up to 28 days ]
- Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions [ Time Frame: Up to 21 days ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856827
Netherlands | |
Centre for Human Drug Research | |
Leiden, Netherlands, 2333 CL |
Study Director: | Chad Glasser, PharmD | Cyclerion Therapeutics, Inc | |
Principal Investigator: | Geert J Groeneveld, MSc | Centre for Human Drug Research |
Responsible Party: | Cyclerion Therapeutics |
ClinicalTrials.gov Identifier: | NCT03856827 |
Other Study ID Numbers: |
C6463-101 CY6463 ( Other Identifier: Cyclerion Therapeutics ) |
First Posted: | February 27, 2019 Key Record Dates |
Last Update Posted: | November 20, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |