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

Overseen By Koushi Iwata, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Otsuka Pharmaceutical Factory, Inc.

Disqualifiers: Diabetes, Bleeding disorders, Thromboembolic, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

84 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called NO-13065 in healthy and obese adults to see if it is safe and how it behaves in the body when taken in different amounts and with food.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy adults with no significant medical history, it's possible that taking medications could affect eligibility.

Is the treatment NO-13065 generally safe for humans?

The safety reporting in clinical trials is often inadequate, with many studies not fully detailing adverse effects or reasons for withdrawal due to toxicity. This makes it difficult to assess the general safety of treatments like NO-13065, as comprehensive safety data may not be available. ^{1 2 3 4 5}

Research Team

Koushi Iwata

Principal Investigator

Otsuka Pharmaceutical Factory, Inc.

Eligibility Criteria

Inclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending oral doses of NO-13065 to assess safety, tolerability, and pharmacokinetics

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NO-13065
• Placebo

Participant Groups

Group I: NO-13065, oral tablet Experimental Treatment 1 Intervention

Group II: Placebo matched to NO-13065, oral tablet Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Factory, Inc.

Lead Sponsor

Trials

2

Recruited

100+

Celerion

Industry Sponsor

Trials

85

Recruited

7,600+

Dr. Susan Thornton

Celerion

Chief Executive Officer since 2010

PhD in Molecular Biology from the University of Pennsylvania

Dr. Lorraine M. Rusch

Celerion

Chief Medical Officer since 2020

MD from an unspecified institution

Findings from Research

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

In a review of 113 placebo-controlled randomized clinical trials published in 2016, only 19.5% of journal articles and 45.1% of study protocols provided descriptions of placebo contents, highlighting a significant lack of transparency in clinical trial reporting.

None of the journal publications explained the rationale for the choice of placebo ingredients, which raises concerns about the potential effects of active placebos on trial outcomes and complicates the assessment of the safety and efficacy of experimental interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals. Hong, K., Rowhani-Farid, A., Doshi, P.[2023]

This ongoing randomized controlled trial involves 70 patients recovering from dorsal lumbar interbody fusion surgery, investigating the effectiveness of adding open-label placebos to standard opioid treatment to reduce opioid consumption and side effects.

The study aims to provide insights into how open-label placebos can enhance pain management without compromising efficacy, potentially offering a cost-effective strategy to minimize opioid use in acute postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial. Sezer, D., de Leeuw, M., Netzer, C., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial. [2021]