OtherPhase 1NCT03856827
A Study of IW-6463 in Healthy Volunteers
A Phase 1 study testing IW-6463 in people with Other, run by Tisento Therapeutics at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Other
- What is being tested?
- IW-6463
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Feb 2019to 22 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication
- Other exclusion criteria per protocol
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- IW-6463, Matching Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IW-6463Drug
Also called CY6463, zagociguat
IW-6463 Tablet
Matching PlaceboDrug
Matching Placebo Tablet
| Study group | Role | What they receive |
|---|---|---|
| IW-6463 | Experimental | IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food Receives: Drug: IW-6463 |
| Placebo | Placebo comparator | Matching placebo tablets administered orally Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 32 days
After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period
Measured: Up to 28 days
Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start6 Feb 2019
- Primary completion22 Oct 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtherStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tisento Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chad Glasser, PharmD, Study director, Cyclerion Therapeutics, IncGeert J Groeneveld, MSc, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856827
- Sponsor's protocol ID
- C6463-101
- Other IDs
- CY6463
- Status last verified
- Aug 2024
- First submitted
- 20 Feb 2019
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03856827
- Acronym / sponsor ID
- C6463-101
- Conditions
- Other
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tisento TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IW-6463 | Experimental | Drug: IW-6463IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food |
| Placebo | Placebo comparator | Drug: Matching PlaceboMatching placebo tablets administered orally |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication
- Other exclusion criteria per protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IW-6463Also: CY6463, zagociguatIW-6463 Tablet | Drug | IW-6463 |
| Matching PlaceboMatching Placebo Tablet | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
Related trials for Other
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad Glasser, PharmD study director
Cyclerion Therapeutics, Inc
Geert J Groeneveld, MSc principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IW-6463 in people with Other, run by Tisento Therapeutics at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.