Tolerability Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets

NCT07300046 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ASP-019-Met
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, randomized study evaluating the tolerability of two concentrations of liquid metformin formulations (100 mg/mL and 250 mg/mL) compared with standard immediate-release metformin tablets in healthy adult subjects. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Incidence of Gastrointestinal Treatment-Emergent Adverse Events (GI TEAEs)

  From each study dose through 24 hours postdose in each treatment period

• Severity of Gastrointestinal Treatment-Emergent Adverse Events

  From each study dose through 24 hours postdose in each treatment period

Study Arms (1)

Single-Arm Crossover

EXPERIMENTAL

Drug: Liquid Metformin 100 mg/mL; Drug: Liquid Metformin 250 mg/mL; Drug: Standard Metformin Immediate-Release Tablet

Interventions

Liquid Metformin 250 mg/mL DRUG

A single oral dose of a liquid metformin formulation at a concentration of 250 mg/mL will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.

Single-Arm Crossover

Standard Metformin Immediate-Release Tablet DRUG

A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.

Single-Arm Crossover

Liquid Metformin 100 mg/mL DRUG

A single oral dose of a liquid metformin formulation at a concentration of 100 mg/mL will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.

Single-Arm Crossover

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female adults 18 to 55 years of age, inclusive.
• Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
• Medically healthy based on medical history, physical examination, vital signs, clinical laboratory evaluations, and 12-lead ECG, in the opinion of the investigator.
• Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.
• Able to provide written informed consent before any study-specific procedures are conducted.
• Willing and able to comply with all study requirements, including fasting, dosing restrictions, and safety/tolerability assessments.
• Females of childbearing potential must use acceptable contraception as determined by the investigator.

You may not qualify if:

• Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.
• History or presence of clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the investigator's opinion, could interfere with participation or data interpretation.
• Estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m², or any clinically significant abnormal clinical laboratory findings.
• Prior history of lactic acidosis.
• Current or recent (within 14 days before first dose) use of prescription drugs, over-the-counter medications, herbal products, or dietary supplements, unless approved by the investigator.
• Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
• Positive urine drug screen or positive alcohol breath test at screening or at check-in.
• Participation in another clinical trial or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before first study dose.
• Donation of ≥450 mL of blood, or significant blood loss, within 8 weeks before the first study dose.
• Pregnant or breastfeeding females.
• Women of childbearing potential not using acceptable contraception.
• Any condition or finding that, in the opinion of the investigator, would make the subject unsuitable for the study.

Sponsors & Collaborators

• Aspargo Labs, Inc: lead

Central Study Contacts

Avi Guralnik

CONTACT

17189381157; avi.berg@synergy-cro.com

Study Design

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

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share