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A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04876924
Recruitment Status : Completed
First Posted : May 7, 2021
Last Update Posted : March 21, 2022
Sponsor:
Collaborator:
Celerion
Information provided by (Responsible Party):
Cantero Therapeutics, a BridgeBio company

Tracking Information
First Submitted Date  ICMJE May 3, 2021
First Posted Date  ICMJE May 7, 2021
Last Update Posted Date March 21, 2022
Actual Study Start Date  ICMJE April 29, 2021
Actual Primary Completion Date February 27, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2021)
Safety and Tolerability [ Time Frame: Baseline to Day 20 ]
Incidence of Adverse Events (AEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2021)
  • Pharmacokinetic Assessments: Cmax [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline ]
    Baseline plasma glycolate
  • Pharmacodynamic Assessment: Percentage change from baseline plasma glycolate [ Time Frame: 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
  • Pharmacodynamic Assessment: Baseline 24 Hour urinary glycolate:creatinine ratio [ Time Frame: Baseline ]
    Baseline 24 Hour urinary glycolate:creatinine ratio
  • Pharmacodynamic Assessment: Percentage change from baseline of 24 Hour urinary glycolate:creatinine ratio [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers
Official Title  ICMJE A Phase 1, Randomized, Double-Blinded, Placebo-controlled, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of BBP-711 (ORF-229) in Healthy Adult Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BBP-711
    BBP-711, oral suspension
  • Drug: Placebo
    Placebo matching BBP-711
Study Arms  ICMJE
  • Experimental: BBP-711 for SAD
    A single dose of BBP-711 will be administered orally.
    Intervention: Drug: BBP-711
  • Placebo Comparator: Placebo for SAD
    A single dose of matching placebo will be administered orally.
    Intervention: Drug: Placebo
  • Experimental: BBP-711 for MAD
    A dose of BBP-711 will be administered orally for multiple days.
    Intervention: Drug: BBP-711
  • Placebo Comparator: Placebo for MAD
    A dose of matching placebo will be administered orally for multiple days.
    Intervention: Drug: Placebo
  • Experimental: BBP-711 for SAD Food Effect
    A single dose of BBP-711 will be administered orally.
    Intervention: Drug: BBP-711
  • Placebo Comparator: Placebo for SAD Food Effect
    A single dose of matching placebo will be administered orally.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2022)
92
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2021)
96
Actual Study Completion Date  ICMJE February 27, 2022
Actual Primary Completion Date February 27, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04876924
Other Study ID Numbers  ICMJE ORF-01-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cantero Therapeutics, a BridgeBio company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cantero Therapeutics, a BridgeBio company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Celerion
Investigators  ICMJE
Principal Investigator: Terry O'Reilly, MD Celerion
PRS Account Cantero Therapeutics, a BridgeBio company
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP