HealthyPhase 1NCT06705088
Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SUVN-I6107 In Healthy Participants
A Phase 1 study testing SUVN-I6107 in people with Healthy, run by Suven Life Sciences Limited at 1 site in United States.
Trial summary
The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses at increasing dose levels, 2) to determine the pharmacokinetic (PK) profile after single and multiple ascending oral doses, 3) to investigate the effects of… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SUVN-I6107
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to 2 Dec 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI): 18.0 to 30.0 kg/m2 for Segment 1 and 18.0 to 32.0 kg/m2 for Segment 2, inclusive, at screening and weight at least 50 kg and no more than 100 kg.
- Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to each admission to the clinical facility until study discharge.
- All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator, at screening and at admission.
Who cannot join
- Females who are pregnant, lactating, planning to become pregnant, or planning to donate ova/oocytes during this study or within 30 days after last administration of study drug.
- Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of admission to the clinical site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-In-Human, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Oral Dose Study Of SUVN-I6107 To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics In Healthy Subjects
The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses at increasing dose levels, 2) to determine the pharmacokinetic (PK) profile after single and multiple ascending oral doses, 3) to investigate the effects of food on SUVN-I6107 pharmacokinetics and 4) to evaluate the pharmacodynamic (PD) effects of single and multiple ascending oral doses of SUVN-I6107 on quantitative electroencephalogram (qEEG) and event-related potential (ERP) assessments.
Read the detailed description
This research study is a randomized, single-center, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD), first-in-human study in healthy participants.
This study consist of 2 segments: Segment 1 will be the SAD portion and Segment 2 will be the MAD portion.
Segment 1 will include up to 5 sequential cohorts. Up to 40 healthy male or female subjects, ages 18 - 45 years (inclusive) old at screening will be enrolled.
Segment 2 will include up to 3 sequential cohorts. The dosing will be administered for 14 consecutive days. Up to 24 healthy male or female subjects, ages 50 to 80 years (inclusive) old at screening will be enrolled.
- Conditions
- Healthy
- Being tested
- SUVN-I6107, Placebo
- Keywords
- SUVN-I6107, First-in-Human, Muscarinic M1 Receptor Positive Allosteric Modulator (M1-PAM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUVN-I6107Drug
SUVN-I6107 Tablet
PlaceboDrug
A look-alike tablet with no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | single ascending doses administered orally Receives: Drug: SUVN-I6107; Drug: Placebo |
| Multiple Ascending Dose | Experimental | multiple ascending doses administered orally for 14 days. Receives: Drug: SUVN-I6107; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
Number of participants with adverse events (AE), discontinuations due to AE or serious adverse event [SAE], and withdrawals from the study due to AE.
Measured: From Day 1 to Day 11 (Segment 1) and from Day 1 to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Descriptive statistics of QTcF for observed values and changes from baseline will be summarized at each scheduled time point.
Measured: From Baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Blood Pressure
Measured: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Pulse Rate
Measured: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Body Temperature
Measured: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Respiration Rate
Measured: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Measured: From baseline to Day 24 (Segment 2)
Secondary outcomes (4)
Area under the concentration-time curve (AUC)
SUVN-I6107 concentrations levels will be assessed after single and multiple ascending oral doses.
Measured: Day 1 and Day 14
Maximum observed concentration (Cmax)
SUVN-I6107 maximum observed concentration will be assessed after single and multiple ascending oral doses.
Measured: Day 1 and Day 14
Time to reach maximum concentration (Tmax)
Time to reach maximum concentration will be assessed after single and multiple ascending oral doses.
Measured: Day 1 and Day 14
Terminal half-life (t½)
SUVN-I6107 elimination rate will be assessed after single and multiple ascending oral doses.
Measured: Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start7 Jan 2025
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suven Life Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705088
- Sponsor's protocol ID
- S1-I6107
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Oral Dose Study Of SUVN-I6107 To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics In Healthy Subjects
- ClinicalTrials.gov ID
- NCT06705088
- Acronym / sponsor ID
- S1-I6107
- Conditions
- Healthy
- Keywords
- SUVN-I6107, First-in-Human, Muscarinic M1 Receptor Positive Allosteric Modulator (M1-PAM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Suven Life Sciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 26 Nov 2024 (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.
The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses at increasing dose levels, 2) to determine the pharmacokinetic (PK) profile after single and multiple ascending oral doses, 3) to investigate the effects of food on SUVN-I6107 pharmacokinetics and 4) to evaluate the pharmacodynamic (PD) effects of single and multiple ascending oral doses of SUVN-I6107 on quantitative electroencephalogram (qEEG) and event-related potential (ERP) assessments.
Detailed description
This research study is a randomized, single-center, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD), first-in-human study in healthy participants.
This study consist of 2 segments: Segment 1 will be the SAD portion and Segment 2 will be the MAD portion.
Segment 1 will include up to 5 sequential cohorts. Up to 40 healthy male or female subjects, ages 18 - 45 years (inclusive) old at screening will be enrolled.
Segment 2 will include up to 3 sequential cohorts. The dosing will be administered for 14 consecutive days. Up to 24 healthy male or female subjects, ages 50 to 80 years (inclusive) old at screening will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: SUVN-I6107, Drug: Placebosingle ascending doses administered orally |
| Multiple Ascending Dose | Experimental | Drug: SUVN-I6107, Drug: Placebomultiple ascending doses administered orally for 14 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI): 18.0 to 30.0 kg/m2 for Segment 1 and 18.0 to 32.0 kg/m2 for Segment 2, inclusive, at screening and weight at least 50 kg and no more than 100 kg.
- Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to each admission to the clinical facility until study discharge.
- All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator, at screening and at admission.
Key exclusion criteria (3 listed)
- Females who are pregnant, lactating, planning to become pregnant, or planning to donate ova/oocytes during this study or within 30 days after last administration of study drug.
- Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of admission to the clinical site.
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 |
|---|---|---|
| SUVN-I6107SUVN-I6107 Tablet | Drug | Multiple Ascending Dose, Single Ascending Dose |
| PlaceboA look-alike tablet with no active ingredient. | Drug | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: From Day 1 to Day 11 (Segment 1) and from Day 1 to Day 24 (Segment 2)
Number of participants with adverse events (AE), discontinuations due to AE or serious adverse event [SAE], and withdrawals from the study due to AE.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: From Baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Descriptive statistics of QTcF for observed values and changes from baseline will be summarized at each scheduled time point.
Number of Participants With Clinically Significant Changes in Blood Pressure
Time frame: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Pulse Rate
Time frame: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Body Temperature
Time frame: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Number of Participants With Clinically Significant Changes in Respiration Rate
Time frame: From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: From baseline to Day 24 (Segment 2)
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
4 secondary outcomes
Area under the concentration-time curve (AUC)
Time frame: Day 1 and Day 14
Maximum observed concentration (Cmax)
Time frame: Day 1 and Day 14
Time to reach maximum concentration (Tmax)
Time frame: Day 1 and Day 14
Terminal half-life (t½)
Time frame: Day 1 and Day 14
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SUVN-I6107 in people with Healthy, run by Suven Life Sciences Limited 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 3 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 7 Apr 2026. 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. 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?
Number of participants with treatment-related adverse events (time frame: From Day 1 to Day 11 (Segment 1) and from Day 1 to Day 24 (Segment 2)). 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 7 Apr 2026.