NCT04838639

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

November 2, 2023

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

March 30, 2021

Last Update Submit

October 31, 2023

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 35 days

Secondary Outcomes (5)

  • Maximum plasma concentration (Cmax)

    Up to 35 days

  • Area under the plasma concentration-time curve (AUC)

    Up to 35 days

  • Time to reach Cmax (Tmax)

    Up to 35 days

  • Apparent first-order terminal elimination half-life (t ½)

    Up to 35 days

  • Correlation between QTc and NO-13065 plasma concentrations

    Up to 29 days

Study Arms (2)

NO-13065, oral tablet

EXPERIMENTAL
Drug: NO-13065

Placebo matched to NO-13065, oral tablet

PLACEBO COMPARATOR
Drug: Placebo

Interventions

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.

NO-13065, oral tablet
PlaceboDRUG

Two subjects per cohort will take a matched placebo.

Placebo matched to NO-13065, oral tablet

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Koushi Iwata

    Otsuka Pharmaceutical Factory, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 9, 2021

Study Start

June 14, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

November 2, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)