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HealthyPhase 1NCT05316259

A Food-Effect Study of BPI-16350 in Healthy Subjects

A Phase 1 study testing BPI-16350 in people with Healthy, run by Betta Pharmaceuticals 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 is intended to quantify the effect of food on the pharmacokinetics of BPI-16350. Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BPI-16350
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
15 Apr 2022to 30 Aug 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

  • Healthy subjects aged 18~45 (including 18 and 45 years old);
  • Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;
  • Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
  • The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
  • Able to comprehend and willing to sign an informed consent form.

Who cannot join

  • History of significant hypersensitivity to any drug compound or food；
  • Significant history or clinical manifestation of any significant cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, musculoskeletal,hematological disorder；
  • Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody is positive；
  • Family history of long QTc syndrome; History or presence of an abnormal ECG；
  • Drug abusers, smokers or alcoholics；
  • Use of any medications within 14 days prior to the first administration；
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  • Donation of blood ≥ 200 mL or receipt of blood products within 3 months before enrollment, or plan on blood donation during the study period；
  • Participation in any other investigational drug study or receive any vaccine within 3 months before enrollment；
  • Female subjects who are pregnant or lactating；the serum HCG test of women with fertility is postive at Screening.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100069

Other trials in China

About this study

Official title: A Phase 1, Single-center, Open-Label, Randomized, 2 Period Crossover Study to Estimate the Effect of Food on the Pharmacokinetics of BPI-16350 in Chinese Healthy Volunteers After a Single Oral Administration

This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.

Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).

Conditions
Healthy
Being tested
BPI-16350

What participants receive

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

  • BPI-16350Drug

    Administered orally

Study groups in NCT05316259
Study groupRoleWhat they receive
Group A（Dosing in the fasted state followed by fed dosing）ExperimentalDosing in the fasted state followed by fed dosing.A washout period of 14 days will be maintained between the 2 treatment periods.
Receives: Drug: BPI-16350
Group B（Dosing in the fed state followed by fasted dosing）ExperimentalDosing in the fed state followed by fasted dosing.A washout period of 14 days will be maintained between the 2 treatment periods.
Receives: Drug: BPI-16350

What is being measured

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

  1. Cmax

    Maximum observed concentration

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

  2. AUC0-t

    Area under the concentration-time curve from time 0 to time t

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

  3. AUC0-∞

    Area under the concentration-time curve from time 0 to infinity

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

Secondary outcomes (8)

  1. Tmax

    Time to reach maximum observed plasma concentration

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

  2. t1/2

    Half-life time

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

  3. λz

    Elimination rate constant

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

  4. tlag

    Lag Time

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

  5. AUC %Extrap

    Percentage of AUCinf due to extrapolation from Tlast to infinity

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

  6. CL/F

    Apparent Oral Clearance

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

  7. V/F

    Apparent Volume of Distribution

    Measured: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose

  8. Characterize the safety of BPI-16350

    Number of subjects with treatment related adverse events

    Measured: from Day 1 to Day 23

Timeline

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

  1. First posted7 Apr 2022
  2. Study start15 Apr 2022
  3. Primary completion30 Aug 2022
  4. Study completion30 Aug 2022

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316259
Sponsor's protocol ID
BTP-66732FE
Status last verified
Apr 2023
First submitted
14 Mar 2022
Last updated
9 May 2023
Results posted
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 BPI-16350 in people with Healthy, run by Betta Pharmaceuticals 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 9 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 9 May 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?

Cmax (time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose). 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 NCT05316259.

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 9 May 2023.

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