Major Depressive DisorderPhase 1SUVN-911NCT03551288
Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects
A Phase 1 study testing SUVN-911 in people with Major Depressive Disorder, run by Suven Life Sciences Limited at 1 site in United States.
Trial summary
The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SUVN-911
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2018to 16 Jul 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects, 18 to 45 years of age (inclusive) for Cohort 1, healthy female subjects, 18 to 45 years of age (inclusive) for Cohort 2, and healthy male subjects ≥ 65 years of age (inclusive) for Cohort 3, at the time of signing the informed consent.
- Subjects in Cohorts 1 and 2 must have a body weight of at least 50 kg and body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive). Elderly subjects in Cohort 3 must have a body weight of at least 50 kg and BMI within the range of 18 to 32 kg/m2 (inclusive)
Who cannot join
- History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 28 days of the first administration of the study treatment (Day 1).
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
- Any positive result at Screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
Trial locations and contacts
1 site in 1 country.
United States1 site
IQVIA Phase One Services, LLC
Kansas City, Kansas, 66211
About this study
Official title: A Phase I, Single-Center, Single Dose Study to Evaluate the Effect of Food, Gender, and Age on Safety and Pharmacokinetic Profiles of SUVN-911 Tablets Orally Administered in Healthy Subjects
The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects
Read the detailed description
This is a Phase I, single-center, open-label, single dose study to evaluate the effect of food, gender, and age on the safety and Pharmacokinetic profiles of single doses of SUVN-911, administered orally in healthy subjects.
The primary objective is to evaluate the effect of food, gender, and age on the pharmacokinetics of a single dose of SUVN-911 administered orally to healthy subjects.
The secondary objective is to evaluate the safety and tolerability of a single dose of SUVN-911 administered orally to healthy adult male, female, and elderly subjects
- Conditions
- Major Depressive Disorder
- Being tested
- SUVN-911
- Keywords
- SUVN-911, Depression, alpha4 beta2 receptor
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUVN-911Drug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Food Effect Cohort | Experimental | Twelve healthy male subjects 18 to 45 years of age, inclusive, will be administered a single oral dose of SUVN-911 on Day 1 (Period 1) and Day 8 (Period 2) with and without food in a crossover manner. Receives: Drug: SUVN-911 |
| Gender Effect Cohort | Experimental | Eight healthy female subjects 18 to 45 years of age, inclusive, will be administered a single dose of SUVN-911. Receives: Drug: SUVN-911 |
| Age Effect Cohort | Experimental | Eight healthy male subjects ≥ 65 years of age will be administered a single oral dose of SUVN-911. Receives: Drug: SUVN-911 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under concentration (AUC)
Plasma concentration versus time
Measured: 24 hours
Secondary outcomes (1)
Vital signs
blood pressure determination
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start22 May 2018
- Primary completion10 Jul 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be enrolled in 1 of 3 cohorts; Cohort 1 (Food Effect Cohort), Cohort 2 (Gender Effect Cohort), and Cohort 3 (Age Effect Cohort). Subjects in Cohort 1 will receive a single oral dose of SUVN-911 on Day 1 under fasted or fed conditions and again on Day 8 under fasted or fed conditions (crossover design). Subjects in Cohort 2 and Cohort 3 will receive a single oral dose of SUVN-911 on Day 1.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suven Life Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Lomeli, MD, Principal investigator, IQVIA Phase One Services, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551288
- Sponsor's protocol ID
- CTP1S2911A4B2
- Acronym
- SUVN-911
- Status last verified
- Aug 2018
- First submitted
- 28 May 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nirogi R, Benade V, Goyal VK, Pandey SK, Mohammed AR, Shinde A, Dogiparti D, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of Ropanicant (SUVN-911), a Novel Alpha4 Beta2 Nicotinic Acetylcholine Receptor (alpha4beta2 nAChR) Antagonist, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2022 Sep;42(9):747-762. doi: 10.1007/s40261-022-01189-9. Epub 2022 Aug 13.
PubMed 35963959
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Single Dose Study to Evaluate the Effect of Food, Gender, and Age on Safety and Pharmacokinetic Profiles of SUVN-911 Tablets Orally Administered in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03551288
- Acronym / sponsor ID
- SUVN-911 / CTP1S2911A4B2
- Conditions
- Major Depressive Disorder
- Keywords
- SUVN-911, Depression, alpha4 beta2 receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Suven Life Sciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 May 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 11 Jun 2018 (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 the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-911 in Healthy Subjects
Detailed description
This is a Phase I, single-center, open-label, single dose study to evaluate the effect of food, gender, and age on the safety and Pharmacokinetic profiles of single doses of SUVN-911, administered orally in healthy subjects.
The primary objective is to evaluate the effect of food, gender, and age on the pharmacokinetics of a single dose of SUVN-911 administered orally to healthy subjects.
The secondary objective is to evaluate the safety and tolerability of a single dose of SUVN-911 administered orally to healthy adult male, female, and elderly subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will be enrolled in 1 of 3 cohorts; Cohort 1 (Food Effect Cohort), Cohort 2 (Gender Effect Cohort), and Cohort 3 (Age Effect Cohort). Subjects in Cohort 1 will receive a single oral dose of SUVN-911 on Day 1 under fasted or fed conditions and again on Day 8 under fasted or fed conditions (crossover design). Subjects in Cohort 2 and Cohort 3 will receive a single oral dose of SUVN-911 on Day 1.
| Arm | Type | Receives |
|---|---|---|
| Food Effect Cohort | Experimental | Drug: SUVN-911Twelve healthy male subjects 18 to 45 years of age, inclusive, will be administered a single oral dose of SUVN-911 on Day 1 (Period 1) and Day 8 (Period 2) with and without food in a crossover manner. |
| Gender Effect Cohort | Experimental | Drug: SUVN-911Eight healthy female subjects 18 to 45 years of age, inclusive, will be administered a single dose of SUVN-911. |
| Age Effect Cohort | Experimental | Drug: SUVN-911Eight healthy male subjects ≥ 65 years of age will be administered a single oral dose of SUVN-911. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male subjects, 18 to 45 years of age (inclusive) for Cohort 1, healthy female subjects, 18 to 45 years of age (inclusive) for Cohort 2, and healthy male subjects ≥ 65 years of age (inclusive) for Cohort 3, at the time of signing the informed consent.
- Subjects in Cohorts 1 and 2 must have a body weight of at least 50 kg and body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive). Elderly subjects in Cohort 3 must have a body weight of at least 50 kg and BMI within the range of 18 to 32 kg/m2 (inclusive)
Key exclusion criteria (5 listed)
- History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 28 days of the first administration of the study treatment (Day 1).
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
- Any positive result at Screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
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-911Tablet | Drug | Age Effect Cohort, Food Effect Cohort, Gender Effect Cohort |
Primary outcome
Area under concentration (AUC)
Time frame: 24 hours
Plasma concentration versus time
1 secondary outcome
Vital signs
Time frame: 24 hours
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 9 Aug 2018.
- Derived from this study: PubMed 35963959Nirogi R, Benade V, Goyal VK, Pandey SK, Mohammed AR, Shinde A, Dogiparti D, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of Ropanicant (SUVN-911), a Novel Alpha4 Beta2 Nicotinic Acetylcholine Receptor (alpha4beta2 nAChR) Antagonist, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2022 Sep;42(9):747-762. doi: 10.1007/s40261-022-01189-9. Epub 2022 Aug 13.
- 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.
Barbara Lomeli, MD principal investigator
IQVIA Phase One Services, LLC
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-911 in people with Major Depressive Disorder, 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 2 inclusion and 5 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 9 Aug 2018. 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?
Area under concentration (AUC) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03551288, which also lists 1 linked publication.
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 9 Aug 2018.