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

NCT06846567 | Completed Phase 1

• 1 other identifier: BM-CR-2216-101P/102P/103P
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The plasma concentration of study drugs

  Plasma concentration of study drugs will be measured at all the time points.

  Blood samples were collected from 0 hours to 32 hours after administration.

Secondary Outcomes (1)

• Frequency of occurrence of adverse events

  0 hours to 48 hours after administration.

Study Arms (3)

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.

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.

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).

Drug: Mirogabalin Besilate Tablets; Drug: BM2216 Extended-Release Tablets(16.5mg)

Interventions

BM2216 Extended-Release tablets（5.5mg） DRUG

5.5mg BM2216 Extended-Release ,test drug

Part 2

Mirogabalin Besilate Tablets DRUG

15mg of Mirogabalin Besilate Tablets,reference drug

Part 1; Part 3

BM2216 Extended-Release Tablets(11mg) DRUG

11mg of BM2216 Extended-Release,test drug

Part 2

BM2216 Extended-Release Tablets(16.5mg) DRUG

16.5mg of BM2216 Extended-Release Tablets,test drug

Part 1; Part 2; Part 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Zhejiang Anglikang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chongqing Bishan People's Hospital

Chongqing, Chongqing Municipality, 402760, China

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 26, 2025
• Study Start: December 1, 2024
• Primary Completion: January 4, 2025
• Study Completion: January 12, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)