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Overweight and ObesityPhase 1DA168NCT06534346

The Food Effect on Pharmacokinetics of DA-302168S

A Phase 1 study testing 15 mg DA-302168S tablet in people with Overweight and Obesity, run by Chendu DIAO Pharmaceutical Group CO., LTD. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be conducted to determine the effect of food on the pharmacokinetics characteristic of DA-302168S following administration of a DA-302168S tablet with and without a high-fat meal. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
What is being tested?
15 mg DA-302168S tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
18 Jul 2024to 3 Aug 2024
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18 to 55 years old (including 18 and 55 years old), male or female.
  • Weight: male ≥50kg, female ≥45kg, body mass index (BMI) in the range of 19.0 ~ 28.0kg/m2 (including the end value).
  • Subjects and their spouses or partners did not plan to become pregnant or plan to donate sperm or ovum during the study period until 3 months after the last dose, and agreed to use at least one acceptable and effective contraceptive method
  • Subjects and their spouses or partners did not plan to become pregnant or plan to donate sperm or eggs during the study period until 3 months after the last dose, and agreed to use at least one acceptable and effective contraceptive method.
  • No clinically significant abnormalities identified in the judgement of investigator at screening.
  • Written informed consent prior to any study specific procedures.

Who cannot join

  • subjects with a history of abnormal clinical presentation, diseases to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, endocrine system, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, and a history of malignant tumors, which are judged to be clinically significant by the Investigator.
  • Use of any medication (including prescription, over-the-counter, herbal, etc.) or nutraceutical within 14 days prior to the first dose.
  • May have any contraindications, allergies or hypersensitivity to DA-302168S Tablets (both test drug and placebo) or its excipients, GLP-1RA, DPP-4 analogues.
  • Previous family history of medullary thyroid carcinoma or type 2 multiple endocrine adenoma syndrome.
  • History or evidence of any of the following conditions:
  • decompensated heart failure (New York Heart Association (NYHA) Cardiac Classification III and IV [Appendix 5: NYHA Heart Failure Classification]), cardiac arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, second or third degree atrioventricular block, QTcF intervals > 450 milliseconds for men or > 470 milliseconds for women [Appendix 8: Fridericia Method Corrected QT Interval Formula], PR intervals > 220 milliseconds, etc.) prior to the first administration of the study drug. (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, grade II or III AV block, QTcF interval >450 ms in males or >470 ms in females [Appendix 8: Formula for Correcting QT Intervals by the Fridericia Method], PR interval >220 ms, etc.) and who, in the opinion of the investigator, are unsuitable for participation in this study;
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  • Serious trauma or acute infection that may affect glycemic control within 4 weeks prior to screening;
  • Positive results for any of the Hepatitis B Surface Antigen, Hepatitis C Antibody, Syphilis Spirochete Antibody, or Human Immunodeficiency Virus (HIV) Antibody;
  • Mental or neurological illness prior to screening, unwillingness to communicate, or a language barrier that prevents full understanding and cooperation;
  • Other medical or psychiatric conditions that may increase the risk of participation in the study or that, in the judgment of the Investigator, may make the subject unsuitable for participation in the study, including a recent history (within the past two years) of major depression or other serious mental disorder, or any history of attempted suicide.
  • Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg prior to the first dose and who, in the opinion of the investigator, are not suitable for participation in the study.
  • Those who screen positive for substance abuse or have a history of substance abuse within the past five years or have used drugs in the 3 months prior to screening.
  • Those who have participated in a clinical trial of another drug within 3 months prior to screening and have received any of the clinical trial drugs.
  • Elective surgery was planned during the study period.
  • Those who have donated or lost ≥200mL of blood, received a blood transfusion, or used blood products within 3 months prior to screening.
  • Female subjects are pregnant or lactating.
  • Those who consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) per day, or who consumed tea, coffee and/or caffeinated beverages within 48 hours prior to the first dose of the drug, or who were unable to discontinue consumption during the trial period
  • Previous chronic intake of xanthine- or grapefruit-rich beverages or foods, or consumption of any xanthine- or grapefruit-rich product within 48 hours prior to the first dose.
  • Smokers or those who smoked an average of ≥5 cigarettes per day in the 3 months prior to screening, or those who were unable to stop using any tobacco-based products during the trial.
  • Heavy drinkers or regular drinkers in the 3 months prior to screening, i.e., those who consume more than 14 standardized units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) or those who have a positive breath test for alcohol at baseline or who are unable to discontinue the use of any alcohol-containing product during the test period.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gulou Hospital Affiliated to Nanjing Medical University

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: A Randomized, Open, Single-dose, Two-cycle, Two-sequence, Cross-over Design Phase I Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profile of a Single Oral DA-302168S Tablet in Healthy Subjects

This study will be conducted to determine the effect of food on the pharmacokinetics characteristic of DA-302168S following administration of a DA-302168S tablet with and without a high-fat meal.

Read the detailed description

This study plans to enroll 16 participants. Qualified subjects will be randomly assigned to one of two dosing sequences (The first group will receive DA-302168S tablets on an fasting condition, followed by administration after high-fat meals. The second group adopts the opposite administration methods) in a 1:1 ratio. Each administration sequence consists of two cycles, with one administration per cycle and a 5-day washout period between each administration.

Being tested
15 mg DA-302168S tablet
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 15 mg DA-302168S tabletDrug

    Also called DA168

    Qualified subjects will be randomly assigned to one of two dosing sequences in a 1:1 ratio. Either DA-302168S tablet with food on Day 1 and DA-302168S tablet without food on Day 6 (treatment sequence fed/fasted), or DA-302168S tablet without food on Day 1 and DA-302168S tablet with food on Day 6 (treatment sequence fasted/fed).

    Each administration sequence consists of two cycles, with one administration per cycle and a 5-day washout period between each administration.

Study groups in NCT06534346
Study groupRoleWhat they receive
DA-302168S (fed+fasting)ExperimentalNot described
Receives: Drug: 15 mg DA-302168S tablet
DA-302168S (fasting+fed)ExperimentalNot described
Receives: Drug: 15 mg DA-302168S tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Peak Plasma Concentration of DA-20168S

    Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

  2. Tmax

    Tmax will be determined from the observed plasma concentration data.

    Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

  3. AUC0-t AUC0-t

    AUC, calculated using linear up/ log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration.

    Measured: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.

Secondary outcomes (2)

  1. Number of participants with adverse events (AEs)

    Incidence,duration and severity of adverse events according to NCI-CTCAE v5.0.

    Measured: 13 days

  2. Concentration of blood glucose

    Fasting and postprandial blood glucose will be measured.

    Measured: Pre-dose and postdose on day 1 and day 6.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start18 Jul 2024
  3. Primary completion3 Aug 2024
  4. Study completion3 Aug 2024

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Single-dose clinical trial with healthy volunteers sequentially using a single dose of DA-302168S tablet under fasting and thereafter under fed conditions.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06534346
Sponsor's protocol ID
2024-CP-DA168-04
Acronym
DA168
Status last verified
Apr 2025
First submitted
26 Jul 2024
Last updated
16 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 15 mg DA-302168S tablet in people with Overweight and Obesity, run by Chendu DIAO Pharmaceutical Group CO., LTD. at 1 site in China.

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 6 inclusion and 20 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 16 Apr 2025. 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 China. 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. 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?

Cmax (time frame: Days 1 and 6: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.). The study lists 3 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 NCT06534346.

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 16 Apr 2025.

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