ObesityPhase 1NCT04838639
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects
A Phase 1 study testing NO-13065 in people with Obesity, run by Otsuka Pharmaceutical Factory, Inc. at 1 site in United States.
Trial summary
This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- NO-13065
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 31 Mar 2022
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age
- Continuous non-smoker
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs.
- Women of non-childbearing potential only
- Able to understand and sign a written informed consent form prior to initiation of study procedures.
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence : Familial hyperlipidemia, Diabetes, Bleeding disorder(s), including relevant familial history, Thromboembolic disease, Bleeding in the gastrointestinal tract or CNS, Hepatobillary disease, Gilbert's syndrome
- History or presence of alcohol or drug abuse.
- Has liver function test(s) including ALT, AST, GGT, and/or ALP or total bilirubin that are > ULN at screening or check-in.
- Positive urine drug or alcohol results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 When Administered Orally to Healthy and Obese Adult Subjects
This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects.
- Conditions
- Obesity
- Being tested
- NO-13065, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO-13065Drug
Single ascending doses of NO-13065 in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065.
Single ascending dose of NO-13065 with food effect arm. Multiple ascending doses of NO-13065 for 10 or up to 28 days in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065.
PlaceboDrug
Two subjects per cohort will take a matched placebo.
| Study group | Role | What they receive |
|---|---|---|
| NO-13065, oral tablet | Experimental | Not described Receives: Drug: NO-13065 |
| Placebo matched to NO-13065, oral tablet | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of treatment emergent adverse events (TEAEs)
To assess the safety and tolerability of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Measured: Up to 35 days
Secondary outcomes (5)
Maximum plasma concentration (Cmax)
To assess Cmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Measured: Up to 35 days
Area under the plasma concentration-time curve (AUC)
To assess AUC of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Measured: Up to 35 days
Time to reach Cmax (Tmax)
To assess Tmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Measured: Up to 35 days
Apparent first-order terminal elimination half-life (t ½)
To assess t ½ of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Measured: Up to 35 days
Correlation between QTc and NO-13065 plasma concentrations
To explore the correlation between changes in QTc interval (msec) and NO-13065 plasma concentrations, appropriate correction method for QTc interval calculation such as QTcF will used for analysis.
Measured: Up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start14 Jun 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Factory, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Koushi Iwata, Study chair, Otsuka Pharmaceutical Factory, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838639
- Sponsor's protocol ID
- 360-101
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2021
- Last updated
- 2 Nov 2023
- Results posted
- 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 When Administered Orally to Healthy and Obese Adult Subjects
- ClinicalTrials.gov ID
- NCT04838639
- Acronym / sponsor ID
- 360-101
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Factory, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 9 Apr 2021 (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.
This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NO-13065, oral tablet | Experimental | Drug: NO-13065 |
| Placebo matched to NO-13065, oral tablet | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age
- Continuous non-smoker
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs.
- Women of non-childbearing potential only
- Able to understand and sign a written informed consent form prior to initiation of study procedures.
Key exclusion criteria (6 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence : Familial hyperlipidemia, Diabetes, Bleeding disorder(s), including relevant familial history, Thromboembolic disease, Bleeding in the gastrointestinal tract or CNS, Hepatobillary disease, Gilbert's syndrome
- History or presence of alcohol or drug abuse.
- Has liver function test(s) including ALT, AST, GGT, and/or ALP or total bilirubin that are > ULN at screening or check-in.
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 |
|---|---|---|
| NO-13065Single ascending doses of NO-13065 in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065. Single ascending dose of NO-13065 with food effect arm. Multiple ascending doses of NO-13065 for 10 or up to 28 days in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065. | Drug | NO-13065, oral tablet |
| PlaceboTwo subjects per cohort will take a matched placebo. | Drug | Placebo matched to NO-13065, oral tablet |
Primary outcome
The number and severity of treatment emergent adverse events (TEAEs)
Time frame: Up to 35 days
To assess the safety and tolerability of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
5 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Up to 35 days
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 35 days
Time to reach Cmax (Tmax)
Time frame: Up to 35 days
Apparent first-order terminal elimination half-life (t ½)
Time frame: Up to 35 days
Correlation between QTc and NO-13065 plasma concentrations
Time frame: Up to 29 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 2 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Koushi Iwata study chair
Otsuka Pharmaceutical Factory, Inc.
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 NO-13065 in people with Obesity, run by Otsuka Pharmaceutical Factory, Inc. 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 6 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 2 Nov 2023. 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?
The number and severity of treatment emergent adverse events (TEAEs) (time frame: Up to 35 days). 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 2 Nov 2023.