A Phase 1 Single and Multiple Ascending Dose and Drug Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Maximum Plasma Concentration (Cmax)
Study Overview
Brief Summary
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses and Drug Drug Interaction of MBX 1416 in healthy volunteers
This study includes 3 parts. Part A involves a single dose of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part C involves the evaluation of rosuvastatin and acetaminophen pharmacokinetics in the presence and absence of MBX 1416.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Masking Description
Double Blind
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female and male adults, ages ≥ 18 and ≤ 65 years with a body mass index (BMI) ≥ 18 kg/m² to ≤ 30.0 kg/m² and fasting glucose < 100 mg/dL and HbA1c < 5.7%.
- •Female subjects of childbearing potential (WOCBP) and male subjects must use highly effective contraception.
Exclusion Criteria
- •Pregnant, lactating or intending to become pregnant during the study.
- •Use of weight-lowering pharmacotherapy or participation in a clinical weight control study within the previous 3 months prior to the first dose of study drug.
- •Presence of clinically significant ECG findings
- •Subjects with a prior history of any serious adverse reaction, hypersensitivity or angioedema to GLP-1 receptor agonists, study drug or drug components.
- •Abnormal laboratory results at Screening.
- •History of renal disease or abnormal kidney function tests at Screening
- •Presence of any clinically significant physical exam, ECG, or laboratory findings at screening.
Arms & Interventions
MBX 1416 (Part A)
Single ascending subcutaneous (SC) doses
Intervention: MBX 1416 (Part A) (Drug)
MBX 1416 (Part B)
Repeated ascending subcutaneous (SC) doses
Intervention: MBX 1416 (Part B) (Drug)
Placebo
Intervention: Placebo (Drug)
MBX 1416 (Part C)
Single subcutaneous (SC) dose of MBX 1416, single dose of rosuvastatin and acetaminophen.
Intervention: MBX 1416 (Part C) (Drug)
Outcomes
Primary Outcomes
Maximum Plasma Concentration (Cmax)
Time Frame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)
Time Frame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
Secondary Outcomes
No secondary outcomes reported