Diabetic NeuropathiesPhase 1NCT06846567

Phase I Study of BM2216 ER vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults

A Phase 1 study testing BM2216 Extended-Release tablets（5.5mg）, Mirogabalin Besilate Tablets and BM2216 Extended-Release Tablets(11mg) in people with Diabetic Neuropathies and Diabetes Mellitus, run by Zhejiang Anglikang Pharmaceutical 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

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Diabetic Neuropathies, Diabetes Mellitus
What is being tested?: BM2216 Extended-Release tablets（5.5mg）, Mirogabalin Besilate Tablets and BM2216 Extended-Release Tablets(11mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteChina
Study dates: 1 Dec 2024to 12 Jan 2025
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

Sign the informed consent form before the trial and fully understand the trial content, procedures, and potential adverse reactions;
Be able to complete the study in accordance with the trial protocol requirements;
The subject (and their partner) is willing to voluntarily adopt effective contraceptive measures from screening until 6 months after the last administration of the study drug. Specific contraceptive measures are detailed in Appendix 3;
Male and female subjects aged 18-45 years (inclusive);
Male subjects must weigh no less than 50.0 kg, and female subjects must weigh no less than 45.0 kg. BMI = weight (kg) / height (m²), with a body mass index ranging from 19.0 to 26.0 kg/m² (inclusive).

Who cannot join

Average daily smoking of more than 5 cigarettes within the 3 months prior to screening;
Allergy to any component of the investigational product, or a history of drug, food, or other substance allergies, or a history of allergic diseases;
History of drug abuse and/or alcoholism (alcoholism defined as consuming more than 14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine); history of drug abuse or use of illicit drugs within the past 5 years;
Donation of blood or significant blood loss (>450 mL) within the 3 months prior to screening;
Difficulty swallowing or a history of gastrointestinal, liver, or kidney diseases (regardless of cure status) or surgeries within the 6 months prior to screening that may affect drug absorption or excretion;
Use of strong inhibitors and/or inducers of hepatic metabolic enzymes (CYP1A2, 2B6, 2A6, 2C8, 2C19, 3A4, and 3A5) within 28 days prior to the first dose. Strong inhibitors include ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, troleandomycin, etc. Strong inducers include rifampicin, carbamazepine, phenytoin sodium, St. John's wort, etc. Use of inhibitors or inducers of absorption transporters (e.g., P-gp, BCRP, OATP) and efflux transporters within 28 days prior to the first dose. For details, refer to Appendix 4;

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Use of any prescription drugs, over-the-counter drugs, health supplements, or herbal medicines within 14 days prior to the first dose;
Consumption of any caffeine-rich, xanthine-rich, or CYP3A4 metabolism-affecting foods/beverages (e.g., grapefruit, animal liver, coffee, tea, cola, chocolate, etc.) within 14 days prior to the first dose or during the trial, or engagement in strenuous exercise (e.g., strength training, aerobic training, soccer), or other factors that may affect drug absorption, distribution, metabolism, or excretion;
Significant changes in diet or exercise habits within 7 days prior to the first dose;
Participation in another clinical trial within the 3 months prior to screening (subjects who withdrew from the study before treatment, i.e., were not randomized or did not receive treatment, may be enrolled in this study);
Inability to tolerate high-fat meals or having special dietary requirements, and unwillingness to accept a standardized diet;
Abnormal vital signs during screening (ear temperature <35.7°C or >37.5°C; pulse <60 bpm or >100 bpm; systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <60 mmHg or ≥90 mmHg);
Clinically significant abnormalities in 12-lead electrocardiogram (ECG);
Female subjects who are breastfeeding or have a positive pregnancy test during screening or the trial period;
Clinically significant abnormalities in clinical laboratory tests or other clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular diseases) identified prior to screening;
Positive screening results for viral hepatitis (including hepatitis B and C), HIV antibodies, or syphilis antibodies;
Occurrence of acute illness from the screening phase until before study drug administration;
Consumption of any alcohol-containing products within 24 hours prior to the first dose or a positive alcohol breath test;
Positive urine drug screening;
Inability to tolerate venipuncture or a history of needle or blood phobia;
Vaccination within 4 weeks prior to the first dose or planned vaccination during the study period;
Other conditions deemed by the investigator to make the subject unsuitable for participation in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Chongqing Bishan People's Hospital
Chongqing, Chongqing Municipality, 402760

Other trials in China

About this study

Official title: A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, Food Effect, Single-Dose Proportionality, and Multiple-Dose Pharmacokinetic Comparison With Melogabalin Besilate Tablets After Single and Multiple Oral Administrations of BM2216 Extended-Release Tablets in Healthy Adult Subjects.--Single-Center, Randomized, Open-Label, Parallel/Crossover Design.

A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, Food Effect, Single-Dose Proportionality, and Multiple-Dose Pharmacokinetic Comparison with Melogabalin Besilate Tablets after Single and Multiple Oral Administrations of BM2216 Extended-Release Tablets in Healthy Adult Subjects. To evaluate the pharmacokinetic characteristics of BM2216 Extended-Release Tablets in healthy adult subjects under fasting and postprandial conditions, and to assess the impact of food; to evaluate the dose proportionality following a single administration.To compare the single and multiple dose pharmacokinetic characteristics of BM2216 Extended-Release Tablets with those of Melogabalin Besilate Tablets, and to determine the relative bioavailability.To assess the safety of BM2216 Extended-Release Tablets in healthy adult subjects following single and multiple oral administrations.

Read the detailed description

This study is divided into three parts: PART-1, PART-2, and PART-3. It is planned that PART-2 will prioritize enrollment (all dose groups can be enrolled simultaneously), while PART-1 and PART-3 can also be enrolled concurrently. The doses for PART-1 and PART-3 may be adjusted based on the results of PART-2.

PART-1 (FE + Single-Dose PK Comparison):

A Single-Center, Randomized, Open-Label, Three-Period, Three-Sequence, Three-Way Crossover Study to Evaluate the Pharmacokinetic Characteristics and Food Effect of BM2216 Extended-Release Tablets After Single Oral Administration Under Fasting and High-Fat Meal Conditions in Healthy Adult Subjects, and to Compare the Pharmacokinetic Characteristics with Multiple-Dose Melogabalin Besilate Tablets, Relative Bioavailability, and Safety. This study plans to enroll 18 subjects, who will be randomly assigned to three dosing sequence groups in a 1:1:1 ratio.

PART-2 (Single-Dose Proportionality):

A single-center, open-label, parallel design will be used to evaluate the pharmacokinetic characteristics, dose proportionality, and safety of BM2216 extended-release tablets after a single dose in healthy adult subjects. This study plans to enroll 32 subjects, with four dose groups of BM2216 extended-release tablets (5.5 mg, 11 mg, 16.5 mg, and 33 mg), with 8 subjects in each group.

PART-3 (Multiple-Dose PK Comparison):

This study adopts a single-center, randomized, open-label, two-period, two-sequence, two-crossover design to evaluate the pharmacokinetic characteristics of BM2216 extended-release tablets after multiple oral doses in healthy adult subjects, as well as the pharmacokinetic comparison with multiple doses of mirogabalin besylate tablets, relative bioavailability, and safety. The study plans to enroll 16 subjects, who will be randomly assigned to two dosing sequence groups in a 1:1 ratio.

Conditions: Diabetic Neuropathies, Diabetes Mellitus
Being tested: BM2216 Extended-Release tablets（5.5mg）, Mirogabalin Besilate Tablets, BM2216 Extended-Release Tablets(11mg), BM2216 Extended-Release Tablets(16.5mg)
Medical subject headings: Diabetic Neuropathies, Diabetes Mellitus

What participants receive

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

BM2216 Extended-Release tablets（5.5mg）Drug
5.5mg BM2216 Extended-Release ,test drug
Mirogabalin Besilate TabletsDrug
15mg of Mirogabalin Besilate Tablets,reference drug
BM2216 Extended-Release Tablets(11mg)Drug
11mg of BM2216 Extended-Release,test drug
BM2216 Extended-Release Tablets(16.5mg)Drug
16.5mg of BM2216 Extended-Release Tablets,test drug

Study groups in NCT06846567
Study group	Role	What they receive
Part 1	Experimental	BM2216 Extended-Release Tablets（test drug，16.5mg）：one tablet on an empty stomach and one tablet after a meal,Three cycles, take once per cycle； Mirogabalin Besilate Tablets(reference drug,15mg)：Take half a tablet orally once on an empty stomach,Three cycles, take twice per cycle. Receives: Drug: Mirogabalin Besilate Tablets; Drug: BM2216 Extended-Release Tablets(16.5mg)
Part 2	Experimental	BM2216 Extended-Release Tablets（test drug，5.5mg、11mg）:one tablet after dinner,Single cycle, take once per cycle; BM2216 Extended-Release Tablets（test drug，16.5mg）：Administer one tablet after dinner (16.5mg dose group); administer two tablets after dinner (33mg dose group)，Single cycle, take once per cycle. Receives: Drug: BM2216 Extended-Release tablets（5.5mg）; Drug: BM2216 Extended-Release Tablets(11mg); Drug: BM2216 Extended-Release Tablets(16.5mg)
Part 3	Experimental	BM2216 Extended-Release Tablets(test drug,16.5mg)：Administer one tablet after dinner.Bicyclic, with continuous administration for 4 days each cycle. Mirogabalin Besilate Tablets(reference drug,15mg)：Take half a tablet orally once on an empty stomach，Two cycles, administer continuously for 4 days per cycle (take 8 times per cycle). Receives: Drug: Mirogabalin Besilate Tablets; Drug: BM2216 Extended-Release Tablets(16.5mg)

What is being measured

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

The plasma concentration of study drugs
Plasma concentration of study drugs will be measured at all the time points.
Measured: Blood samples were collected from 0 hours to 32 hours after administration.

Secondary outcomes (1)

Frequency of occurrence of adverse events
Any adverse event were classified by severity, treatment and its relationship with the study drug was evaluated.
Measured: 0 hours to 48 hours after administration.

Timeline

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

1 Dec 202412 Jan 2025

First posted26 Feb 2025
Study start1 Dec 2024
Primary completion4 Jan 2025
Study completion12 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
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: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06846567
Sponsor's protocol ID: BM-CR-2216-101P/102P/103P
Status last verified: Feb 2025
First submitted: 17 Feb 2025
Last updated: 27 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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 Diabetic Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, Food Effect, Single-Dose Proportionality, and Multiple-Dose Pharmacokinetic Comparison With Melogabalin Besilate Tablets After Single and Multiple Oral Administrations of BM2216 Extended-Release Tablets in Healthy Adult Subjects.--Single-Center, Randomized, Open-Label, Parallel/Crossover Design.
ClinicalTrials.gov ID: NCT06846567
Acronym / sponsor ID: BM-CR-2216-101P/102P/103P
Conditions: Diabetic Neuropathies, Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Zhejiang Anglikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Dec 2024 (actual)
Primary completion: 4 Jan 2025 (actual)
Study completion: 12 Jan 2025 (actual)
First posted: 26 Feb 2025 (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

PART-1 (FE + Single-Dose PK Comparison):

PART-2 (Single-Dose Proportionality):

PART-3 (Multiple-Dose PK Comparison):

Study design

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

Arm	Type	Receives
Part 1	Experimental	Drug: Mirogabalin Besilate Tablets, Drug: BM2216 Extended-Release Tablets(16.5mg)BM2216 Extended-Release Tablets（test drug，16.5mg）：one tablet on an empty stomach and one tablet after a meal,Three cycles, take once per cycle； Mirogabalin Besilate Tablets(reference drug,15mg)：Take half a tablet orally once on an empty stomach,Three cycles, take twice per cycle.
Part 2	Experimental	Drug: BM2216 Extended-Release tablets（5.5mg）, Drug: BM2216 Extended-Release Tablets(11mg), Drug: BM2216 Extended-Release Tablets(16.5mg)BM2216 Extended-Release Tablets（test drug，5.5mg、11mg）:one tablet after dinner,Single cycle, take once per cycle; BM2216 Extended-Release Tablets（test drug，16.5mg）：Administer one tablet after dinner (16.5mg dose group); administer two tablets after dinner (33mg dose group)，Single cycle, take once per cycle.
Part 3	Experimental	Drug: Mirogabalin Besilate Tablets, Drug: BM2216 Extended-Release Tablets(16.5mg)BM2216 Extended-Release Tablets(test drug,16.5mg)：Administer one tablet after dinner.Bicyclic, with continuous administration for 4 days each cycle. Mirogabalin Besilate Tablets(reference drug,15mg)：Take half a tablet orally once on an empty stomach，Two cycles, administer continuously for 4 days per cycle (take 8 times per cycle).

Who may qualify

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

Key inclusion criteria (5 listed)

Sign the informed consent form before the trial and fully understand the trial content, procedures, and potential adverse reactions;
Be able to complete the study in accordance with the trial protocol requirements;
The subject (and their partner) is willing to voluntarily adopt effective contraceptive measures from screening until 6 months after the last administration of the study drug. Specific contraceptive measures are detailed in Appendix 3;
Male and female subjects aged 18-45 years (inclusive);
Male subjects must weigh no less than 50.0 kg, and female subjects must weigh no less than 45.0 kg. BMI = weight (kg) / height (m²), with a body mass index ranging from 19.0 to 26.0 kg/m² (inclusive).

Key exclusion criteria (22 listed)

Average daily smoking of more than 5 cigarettes within the 3 months prior to screening;
Allergy to any component of the investigational product, or a history of drug, food, or other substance allergies, or a history of allergic diseases;
History of drug abuse and/or alcoholism (alcoholism defined as consuming more than 14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine); history of drug abuse or use of illicit drugs within the past 5 years;
Donation of blood or significant blood loss (>450 mL) within the 3 months prior to screening;
Difficulty swallowing or a history of gastrointestinal, liver, or kidney diseases (regardless of cure status) or surgeries within the 6 months prior to screening that may affect drug absorption or excretion;

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
BM2216 Extended-Release tablets（5.5mg）5.5mg BM2216 Extended-Release ,test drug	Drug	Part 2
Mirogabalin Besilate Tablets15mg of Mirogabalin Besilate Tablets,reference drug	Drug	Part 1, Part 3
BM2216 Extended-Release Tablets(11mg)11mg of BM2216 Extended-Release,test drug	Drug	Part 2
BM2216 Extended-Release Tablets(16.5mg)16.5mg of BM2216 Extended-Release Tablets,test drug	Drug	Part 1, Part 2, Part 3

Primary outcome

The plasma concentration of study drugs
Time frame: Blood samples were collected from 0 hours to 32 hours after administration.
Plasma concentration of study drugs will be measured at all the time points.

1 secondary outcome

Frequency of occurrence of adverse events
Time frame: 0 hours to 48 hours after administration.

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 27 Feb 2025.
Individual participant dataSharing planned: No

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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?

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 22 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 27 Feb 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?

The plasma concentration of study drugs (time frame: Blood samples were collected from 0 hours to 32 hours after administration.). 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 NCT06846567.

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 27 Feb 2025.