Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects

Sponsor
Otsuka Pharmaceutical Factory, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04838639
Collaborator
Celerion (Industry)
84
1
2
14.6
5.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 14, 2021
Actual Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: NO-13065, oral tablet

Drug: NO-13065
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.

Placebo Comparator: Placebo matched to NO-13065, oral tablet

Drug: Placebo
Two subjects per cohort will take a matched placebo.

Outcome Measures

Primary Outcome Measures

  1. The number and severity of treatment emergent adverse events (TEAEs) [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.

Secondary Outcome Measures

  1. Maximum plasma concentration (Cmax) [Up to 35 days]

    To assess Cmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.

  2. Area under the plasma concentration-time curve (AUC) [Up to 35 days]

    To assess AUC of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.

  3. Time to reach Cmax (Tmax) [Up to 35 days]

    To assess Tmax of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.

  4. Apparent first-order terminal elimination half-life (t ½) [Up to 35 days]

    To assess t ½ of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.

  5. Correlation between QTc and NO-13065 plasma concentrations [Up to 29 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age

  2. Continuous non-smoker

  3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs.

  4. Women of non-childbearing potential only

  5. Able to understand and sign a written informed consent form prior to initiation of study procedures.

Exclusion Criteria:
  1. Subject is mentally or legally incapacitated or has significant emotional problems

  2. History or presence of clinically significant medical or psychiatric condition or disease

  3. 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

  4. History or presence of alcohol or drug abuse.

  5. Has liver function test(s) including ALT, AST, GGT, and/or ALP or total bilirubin that are > ULN at screening or check-in.

  6. Positive urine drug or alcohol results.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Celerion Lincoln Nebraska United States 68502

Sponsors and Collaborators

  • Otsuka Pharmaceutical Factory, Inc.
  • Celerion

Investigators

  • Study Chair: Koushi Iwata, Otsuka Pharmaceutical Factory, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Otsuka Pharmaceutical Factory, Inc.
ClinicalTrials.gov Identifier:
NCT04838639
Other Study ID Numbers:
  • 360-101
First Posted:
Apr 9, 2021
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 20, 2022