HealthyPhase 1NCT02616861
Trial of IW-1973 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy Volunteers
A Phase 1 study testing IW-1973 in people with Healthy, run by Cyclerion Therapeutics at 1 site in United States.
Trial summary
Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IW-1973
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2016
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is an ambulatory male or female between 18 and 55 years old at the Screening Visit
- Subject's body mass index score is > 18.5 and < 30.0 kg/m2 at the Screening Visit
- Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception
- Subject is in good health and has no clinically significant findings on a physical examination
- Other inclusion criteria per protocol
Who cannot join
- History of any clinically significant medical condition
- Other exclusion criteria per protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2-stage Phase 1 Study of Safety, Tolerability, PK, and PD of IW-1973 Tablet in Healthy Volunteers in an Open-label, Single-dose Stage, and a Randomized, Double Blind, Placebo-controlled, Multiple-ascending-dose Stage
Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study.
Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.
- Conditions
- Healthy
- Being tested
- IW-1973, Matching Placebo Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IW-1973Drug
IW-1973 Tablet
Matching Placebo TabletDrug
Matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| IW-1973 | Experimental | 1973 Escalating Doses Receives: Drug: IW-1973 |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Matching Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
Measured: 42 Days
Maximum observed plasma concentration (Cmax)
Measured: 42 Days
Blood Pressure
Measured: 42 days
Area under the plasma concentration time curve during a dosing interval (AUC)
Measured: 42 Days
Time of maximum observed plasma concentration (Tmax)
Measured: 42 Days
Heart rate
Measured: 42 Days
Serum cGMP
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclerion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hanrahan, MD, Study director, Ironwood Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616861
- Sponsor's protocol ID
- ICP-1973-102
- Status last verified
- Apr 2019
- First submitted
- 29 Oct 2015
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-stage Phase 1 Study of Safety, Tolerability, PK, and PD of IW-1973 Tablet in Healthy Volunteers in an Open-label, Single-dose Stage, and a Randomized, Double Blind, Placebo-controlled, Multiple-ascending-dose Stage
- ClinicalTrials.gov ID
- NCT02616861
- Acronym / sponsor ID
- ICP-1973-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cyclerion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Nov 2015 (estimated)
- 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, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of the IW-1973 Tablet administered orally to healthy volunteers, in fed and fasted states, in a single-dose crossover study.
Stage 2: To assess the safety, tolerability, PK profile, and PD effects of a range of doses of IW-1973 Tablet administered orally to healthy subjects in a 21-day, multiple ascending-dose study with optional up-titration of dose level within cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IW-1973 | Experimental | Drug: IW-19731973 Escalating Doses |
| Placebo | Placebo comparator | Drug: Matching Placebo TabletMatching Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is an ambulatory male or female between 18 and 55 years old at the Screening Visit
- Subject's body mass index score is > 18.5 and < 30.0 kg/m2 at the Screening Visit
- Women of childbearing potential must have a negative pregnancy test and must agree to use double-barrier contraception
- Subject is in good health and has no clinically significant findings on a physical examination
- Other inclusion criteria per protocol
Key exclusion criteria (2 listed)
- History of any clinically significant medical condition
- 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-1973IW-1973 Tablet | Drug | IW-1973 |
| Matching Placebo TabletMatching placebo tablet | Drug | Placebo |
Primary outcome
Treatment Emergent Adverse Events
Time frame: 42 Days
Maximum observed plasma concentration (Cmax)
Time frame: 42 Days
Blood Pressure
Time frame: 42 days
Area under the plasma concentration time curve during a dosing interval (AUC)
Time frame: 42 Days
Time of maximum observed plasma concentration (Tmax)
Time frame: 42 Days
Heart rate
Time frame: 42 Days
Serum cGMP
Time frame: 42 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 3 Apr 2019.
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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.
John Hanrahan, MD study director
Ironwood Pharmaceuticals
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-1973 in people with Healthy, run by Cyclerion Therapeutics at 1 site in United States.
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 2 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 3 Apr 2019. 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 United States. 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?
Treatment Emergent Adverse Events (time frame: 42 Days). The study lists 7 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 3 Apr 2019.