Cognitive DisordersPhase 1NCT02575482
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects
A Phase 1 study testing SUVN-D4010 in people with Cognitive Disorders, run by Suven Life Sciences Limited at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 in healthy male subjects following single or multiple ascending doses. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Disorders
- What is being tested?
- SUVN-D4010
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive).
Who cannot join
- Standard exclusion criterion for Phase 1 clinical trial in healthy subjects.
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-D4010 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 in healthy male subjects following single or multiple ascending doses.
Read the detailed description
This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-D4010 administered orally once a day to healthy male subjects. The study will be conducted under double blind conditions.
The primary objective is to evaluate the safety and tolerability of SUVN-D4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-D4010,if possible.
The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of SUVN-D4010 in healthy male subjects.
- Conditions
- Cognitive Disorders
- Being tested
- SUVN-D4010, Placebo
- Keywords
- SUVN-D4010, serotonin 4 (5-HT4) receptor, first in human, safety, pharmacokinetics, tolerability, single dose, repeat dose
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUVN-D4010Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Single and Multiple ascending dose | Experimental | Single dose of SUVN-D4010 in healthy male subjects Receives: Drug: SUVN-D4010 |
| Placebo | Placebo comparator | Placebo in healthy male subjects Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG
Measured: Range of Day 1-17
Physical exams
Measured: Range of Day 1-17
Vitals signs
Measured: Range of Day 1-17
CSSRS (suicidality)
Columbia Suicidal Severity Rating Scale
Measured: Range of Day 1-17
Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects
Incidence of Treatment-Emergent Adverse Events, Laboratory parameters
Measured: Range of Day 1-17
Secondary outcomes (6)
Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau)
Measured: Day 1
Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf)
Measured: Day 14
Maximum observed concentration (Cmax) and time of observation (tmax)
Measured: Day 1 and Day 14
Oral clearance (CL/F)
Measured: Day 1 and Day 14
Accumulation index following multiple dosing of SUVN-D4010 (AI)
Measured: Day 14
Elimination half life (t½)
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 posted14 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionJun 2016
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 Cognitive DisordersStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suven Life Sciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Dickerson, Principal investigator, Research Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575482
- Sponsor's protocol ID
- CTP140105HT4
- Status last verified
- Jun 2016
- First submitted
- 5 Oct 2015
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nirogi R, Bhyrapuneni G, Muddana NR, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT4 Partial Agonist, SUVN-D4010, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2021 May;41(5):469-482. doi: 10.1007/s40261-021-01027-4. Epub 2021 Mar 31.
PubMed 33788154
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SUVN-D4010 After Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02575482
- Acronym / sponsor ID
- CTP140105HT4
- Conditions
- Cognitive Disorders
- Keywords
- SUVN-D4010, serotonin 4 (5-HT4) receptor, first in human, safety, pharmacokinetics, tolerability, single dose, repeat dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Suven Life Sciences LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Oct 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.
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 in healthy male subjects following single or multiple ascending doses.
Detailed description
This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-D4010 administered orally once a day to healthy male subjects. The study will be conducted under double blind conditions.
The primary objective is to evaluate the safety and tolerability of SUVN-D4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-D4010,if possible.
The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of SUVN-D4010 in healthy male subjects.
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 |
|---|---|---|
| Single and Multiple ascending dose | Experimental | Drug: SUVN-D4010Single dose of SUVN-D4010 in healthy male subjects |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo in healthy male subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive).
Key exclusion criteria (3 listed)
- Standard exclusion criterion for Phase 1 clinical trial in healthy subjects.
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
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-D4010 | Drug | Single and Multiple ascending dose |
| Placebo | Drug | Placebo |
Primary outcome
ECG
Time frame: Range of Day 1-17
Physical exams
Time frame: Range of Day 1-17
Vitals signs
Time frame: Range of Day 1-17
CSSRS (suicidality)
Time frame: Range of Day 1-17
Columbia Suicidal Severity Rating Scale
Safety and tolerability of single or multiple doses of SUVN-D4010 in healthy male subjects
Time frame: Range of Day 1-17
Incidence of Treatment-Emergent Adverse Events, Laboratory parameters
6 secondary outcomes
Area under the SUVN-D4010 plasma concentrationtime curve in a dosing interval (AUC0tau)
Time frame: Day 1
Area under the SUVN-D4010 plasma concentrationtime curve from zero to infinity (AUC0inf)
Time frame: Day 14
Maximum observed concentration (Cmax) and time of observation (tmax)
Time frame: Day 1 and Day 14
Oral clearance (CL/F)
Time frame: Day 1 and Day 14
Accumulation index following multiple dosing of SUVN-D4010 (AI)
Time frame: Day 14
Elimination 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 6 Jun 2016.
- Derived from this study: PubMed 33788154Nirogi R, Bhyrapuneni G, Muddana NR, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT4 Partial Agonist, SUVN-D4010, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2021 May;41(5):469-482. doi: 10.1007/s40261-021-01027-4. Epub 2021 Mar 31.
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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.
Daniel Dickerson principal investigator
Research Physician
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-D4010 in people with Cognitive Disorders, 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 1 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 6 Jun 2016. 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?
ECG (time frame: Range of Day 1-17). The study lists 5 primary outcomes in all. 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 NCT02575482, 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 6 Jun 2016.