A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers
- Registration Number
- NCT04876924
- Lead Sponsor
- Cantero Therapeutics, a BridgeBio company
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.
- Detailed Description
This is a single-center, two-part, randomized, double-blinded, placebo-controlled, ascending dose study of BBP-711 in healthy male and female adult volunteers. The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers. Each volunteer will participate in the study for about 20 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- Adult male or female who is 18 to 65 years old,
- Weight >50 kg and ≤110 kg at Screening
- Body mass index (BMI) 20 to 32 kg/m2, inclusive, at Screening
- In generally good health
- Nonsmoker, or not using tobacco or nicotine-containing products for at least 6 months
- Use of any over-the-counter medications, including herbals or routine vitamins or minerals, or other supplements, within 7 days before admission to the research center.
- Pregnant or breastfeeding
- eGFR <90 mL/minute
- Abnormal ECG
- Abnormal laboratory results
- Positive test result for HIV, Hepatitis B, Hepatitis C, or COVID-19
- History of substance dependency (alcohol or other drugs of abuse) in the last 2 years
- Use of study drug in any clinical trial within 30 days of admission to the research center, or in the active follow-up phase of another clinical trial involving study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo for MAD Placebo A dose of matching placebo will be administered orally for multiple days. BBP-711 for SAD Food Effect BBP-711 A single dose of BBP-711 will be administered orally. Placebo for SAD Food Effect Placebo A single dose of matching placebo will be administered orally. Placebo for SAD Placebo A single dose of matching placebo will be administered orally. BBP-711 for SAD BBP-711 A single dose of BBP-711 will be administered orally. BBP-711 for MAD BBP-711 A dose of BBP-711 will be administered orally for multiple days.
- Primary Outcome Measures
Name Time Method Safety and Tolerability Baseline to Day 20 Incidence of Adverse Events (AEs)
- Secondary Outcome Measures
Name Time Method Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD Percentage change from baseline plasma glycolate
Pharmacokinetic Assessments: Cmax Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD Maximum observed plasma concentration (Cmax)
Pharmacokinetic Assessments: Cmin Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD Minimum observed plasma concentration (Cmin)
Pharmacokinetic Assessments: AUC Blood samples will be taken pre-dose up to Day 10 for SAD and pre-dose up to Day 20 for MAD Area under the plasma concentration-time curve from 0 to last measurable concentration (AUC(0-last)) computed using the linear trapezoidal rule
Pharmacodynamic Assessment: Baseline plasma glycolate Baseline Baseline plasma glycolate
Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio Baseline Baseline 24 Hour urinary glycolate:creatinine ratio
Pharmacodynamic Assessment: Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio Urine samples will be taken pre-dose up to Day 3 for SAD and pre-dose up to Day 7 for MAD Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States