Healthy SubjectsPhase 1NCT05150626

A Study to Evaluate the Effect of Different Meal Types on the Pharmacokinetics of DBPR108 in Healthy Subjects

A Phase 1 study testing DBPR108 tablets in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology 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 is an open-label, randomized, three-period, crossover, single-dose study to evaluate the effects of a low-fat meal and a standard meal on the pharmacokinetics of DBPR108 and the safety and tolerability of DBPR108 under different fed states in healthy adult subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: DBPR108 tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteChina
Study dates: 29 May 2022to 14 Jul 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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects fully understand and voluntarily participate in this study and sign informed consent;
Healthy male and/or female subjects between the ages of 18 and 45 years (inclusive);
Body Mass Index (BMI) of 18 to 28 kg/m2 (inclusive), body weight for male ≥50.0 kg and for female≥45.0 kg；
Subjects (including their partners) are willing to use effective contraceptives from screening to the 6 months after the last dose administration;
Subjects judged to be in good health by the investigator, based on the physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination and laboratory examination etc;

Who cannot join

History of allergic conditions, or allergic to any ingredients of DBPR108;
History of severe diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematological, psychiatric/neurological systems diseases within 1 year prior to screening;
History of hypoglycemia or abnormal blood glucose at screening: fasting blood glucose <70 mg/dL (3.9 mmol/L) or >110 mg/dL (6.1 mmol/L);
Subjects who have previously undergone surgery (e.g., subtotal gastrectomy) that may affect the absorption, distribution, metabolism, or excretion of the drug, or who have a scheduled surgery during the study period;
History of drug abuse, or urine drug screening is positive at screening;
Smoking more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using nicotine-containing products during the study period;

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Regular alcohol consumption exceeding 15 g/day(female) or 25 g/day(male) (15 g ≈ 450 mL beer, or 50 mL hard liquor, or 150 mL wine) within the 3 months prior to screening, or taking any product containing alcohol within 48 h before dosing, or alcohol test is positive;
Blood donation (or blood loss) ≥400 mL, or receiving blood product transfusion within 3 months prior to screening;
Consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks), or those who have had strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, within 48 h before the administration;
Use of any prescription drug, over-the-counter drug (except acetaminophen and some nasal sprays), or herbal medicine within 2 weeks prior to screening;
Have special dietary requirements and cannot consume the study meals;
Subject with hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or Treponema pallidum antibody positive;
Enrolled in any other clinical trial within 3 months before screening (whichever is administrated);
Have been vaccinated within 4 weeks prior to screening or who have a scheduled vaccination during the study period;
Pregnant/lactating woman, or who has a positive blood pregnancy test at screening;
Not suitable for this study as decided by the investigator due to other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

First Affiliated Hospital of Soochow University
Suzhou

Other trials in China

About this study

Official title: An Open-label, Randomized, Three-period, Crossover, Single-dose Study to Evaluate the Effect of a Low-fat Meal and a Standard Meal on the Pharmacokinetics of DBPR108 in Healthy Subjects

Read the detailed description

The objective of the study is to evaluate the effect of different meal types on the pharmacokinetics of DBPR108, a potent dipeptidylpeptidase-4 inhibitor. In this open-label, randomized, three-period, crossover study, healthy subjects will receive a single dose of DBPR108 100 mg under fasted conditions and following a low-fat meal or a standard meal. Twenty-one healthy subjects will be randomized 1:1:1 to Sequence A, Sequence B, or Sequence C. This study will consist of a screening and baseline period, a treatment period, and a follow-up period. Blood samples for pharmacokinetic assessments will be taken pre-dose and up to 48 h post-dose.

Conditions: Healthy Subjects
Being tested: DBPR108 tablets

What participants receive

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

DBPR108 tabletsDrug
Drug: DBPR108, tablets, oral

Study groups in NCT05150626
Study group	Role	What they receive
Sequence A administered DBPR108	Experimental	Subjects will receive a single dose of DBPR108 100 mg under fasted condition, following a low-fat meal and a standard meal. Receives: Drug: DBPR108 tablets
Sequence B administered DBPR108	Experimental	Subjects will receive a single dose of DBPR108 100 mg following a low-fat meal and standard meal, under fasted condition. Receives: Drug: DBPR108 tablets
Sequence C administered DBPR108	Experimental	Subjects will receive a single dose of DBPR108 100 mg following a standard meal, under fasted condition, following a low-fat meal. Receives: Drug: DBPR108 tablets

What is being measured

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

Peak plasma concentration (Cmax) of DBPR108
Measured: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Area under the plasma concentration versus time curve from time zero to the time of last measurable concentration (AUClast) of DBPR108
Measured: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Area under the plasma concentration versus time curve from time zero to infinity (AUCinf) of DBPR108
Measured: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.

Secondary outcomes (5)

Time to achieve maximum plasma concentration (Tmax) of DBPR108
Measured: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Half-life (t1/2) of DBPR108
Measured: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Apparent clearance (CL/F) of DBPR108
Measured: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Apparent volume of Distribution (Vz/F) of DBPR108
Measured: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Day 1 to Day 14

Timeline

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

29 May 202214 Jul 2022

First posted9 Dec 2021
Study start29 May 2022
Primary completion7 Jun 2022
Study completion14 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
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: Crossover
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05150626
Sponsor's protocol ID: HA1118-013
Status last verified: Apr 2023
First submitted: 26 Nov 2021
Last updated: 12 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Three-period, Crossover, Single-dose Study to Evaluate the Effect of a Low-fat Meal and a Standard Meal on the Pharmacokinetics of DBPR108 in Healthy Subjects
ClinicalTrials.gov ID: NCT05150626
Acronym / sponsor ID: HA1118-013
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 May 2022 (actual)
Primary completion: 7 Jun 2022 (actual)
Study completion: 14 Jul 2022 (actual)
First posted: 9 Dec 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Sequence A administered DBPR108	Experimental	Drug: DBPR108 tabletsSubjects will receive a single dose of DBPR108 100 mg under fasted condition, following a low-fat meal and a standard meal.
Sequence B administered DBPR108	Experimental	Drug: DBPR108 tabletsSubjects will receive a single dose of DBPR108 100 mg following a low-fat meal and standard meal, under fasted condition.
Sequence C administered DBPR108	Experimental	Drug: DBPR108 tabletsSubjects will receive a single dose of DBPR108 100 mg following a standard meal, under fasted condition, following a low-fat meal.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subjects fully understand and voluntarily participate in this study and sign informed consent;
Healthy male and/or female subjects between the ages of 18 and 45 years (inclusive);
Body Mass Index (BMI) of 18 to 28 kg/m2 (inclusive), body weight for male ≥50.0 kg and for female≥45.0 kg；
Subjects (including their partners) are willing to use effective contraceptives from screening to the 6 months after the last dose administration;
Subjects judged to be in good health by the investigator, based on the physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination and laboratory examination etc;

Key exclusion criteria (16 listed)

History of allergic conditions, or allergic to any ingredients of DBPR108;
History of severe diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematological, psychiatric/neurological systems diseases within 1 year prior to screening;
History of hypoglycemia or abnormal blood glucose at screening: fasting blood glucose <70 mg/dL (3.9 mmol/L) or >110 mg/dL (6.1 mmol/L);
Subjects who have previously undergone surgery (e.g., subtotal gastrectomy) that may affect the absorption, distribution, metabolism, or excretion of the drug, or who have a scheduled surgery during the study period;
History of drug abuse, or urine drug screening is positive at screening;

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
DBPR108 tabletsDrug: DBPR108, tablets, oral	Drug	Sequence A administered DBPR108, Sequence B administered DBPR108, Sequence C administered DBPR108

Primary outcome

Peak plasma concentration (Cmax) of DBPR108
Time frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Area under the plasma concentration versus time curve from time zero to the time of last measurable concentration (AUClast) of DBPR108
Time frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Area under the plasma concentration versus time curve from time zero to infinity (AUCinf) of DBPR108
Time frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.

5 secondary outcomes

Time to achieve maximum plasma concentration (Tmax) of DBPR108
Time frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Half-life (t1/2) of DBPR108
Time frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Apparent clearance (CL/F) of DBPR108
Time frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Apparent volume of Distribution (Vz/F) of DBPR108
Time frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day 1 to Day 14

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 12 Apr 2023.

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Not yet recruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 DBPR108 tablets in people with Healthy Subjects, run by CSPC ZhongQi Pharmaceutical Technology 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 5 inclusion and 16 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 12 Apr 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 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?

Peak plasma concentration (Cmax) of DBPR108 (time frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.). 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 NCT05150626.

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 12 Apr 2023.