- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04939467
Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers
April 14, 2022 updated by: Blade Therapeutics
A Phase 1, Open-Label, Non-Randomized, Fixed Sequence Study to Evaluate the Steady-state Pharmacokinetics of BLD-0409, Nintedanib and Pirfenidone When Administered Concurrently in Healthy Volunteers
A Phase 1, Open-Label, Non-Randomized, Fixed Sequence Study to Evaluate the Steady-state Pharmacokinetics of BLD-0409, Nintedanib and Pirfenidone when Administered Concurrently in Healthy Volunteers
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, open-label study designed to determine the effect of BLD-0409 on the PK of nintedanib and pirfenidone, all at steady state, and to evaluate the safety and tolerability of BLD-0409 administered with either nintedanib or pirfenidone in healthy adult volunteers
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33147
- Advanced Pharma
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female participants 18-55 years of age (inclusive) at the time of signing the ICF.
- Participants must be in good general health, in the opinion of the investigator, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of IP.
- Participants must have clinical laboratory values within normal ranges or < 1.2 times upper limit of normal (ULN) as specified by the testing laboratory, unless deemed not clinically significant (NCS) by the investigator.
- Body mass index (BMI) 18 to ≤ 30 kg/m2.
- Female participants must use double barrier contraception and refrain from oocyte donation from at least 28 days prior to Screening and for 90 days after last dose of IP.
- Male participants and female partners of male participants must agree to use highly effective, double barrier contraception and refrain from sperm donation from first dose of IP and for 90 days after last dose of IP.
- Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. Females not of childbearing potential must be surgically infertile or post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle-stimulating hormone (FSH) level >40 mIU/mL at Screening.
- Participants must provide signed informed consent prior to study entry and have the ability and willingness to attend and comply with the necessary visits at the study site.
Exclusion Criteria:
- Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.
- Presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study per protocol.
- Known cardiac disease.
- Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low grade cervical intraepithelial neoplasia.
- Serious local or systemic infection within 1 month of Screening requiring antibiotic treatment or history of recurrent infections.
- Any acute illness within 30 days prior to Day 1.
- Surgery, bone fracture or major musculoskeletal injury within the past 3 months prior to the first IP administration determined by the investigator to be clinically relevant.
- Positive for human immunodeficiency virus (HIV) antibody or antigen.
- Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
- Systolic blood pressure (BP) > 150 mmHg or < 90 mmHg or diastolic BP >90 mmHg or <50 mmHg at Screening with one repeat allowed per the investigator's discretion at Screening and Day -1.
- Heart rate < 40 beats per minute (bpm) or > 100 bpm at Screening.
- Prolonged QT interval corrected by Fridericia's formula (QTcF) (>450 ms for males and >470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the investigator.
- All prescription and over-the-counter medications (including herbal medications), except for contraceptives, are prohibited within 7 days prior to the first IP administration and throughout the entire duration of the study.
- All vaccines within 14 days prior to first IP administration and throughout the entire duration of the study.
- Administration of investigational product in another study within 30 days prior to the first IP administration (except BLD-0409), or five half-lives, whichever is longer.
- Significant weight loss or gain between Screening and first IP administration.
- Blood donation or significant blood loss within 60 days prior to the first IP administration.
- Plasma donation within 7 days prior to the first IP administration.
- Females who are pregnant or breastfeeding.
- Diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.) within 7 days prior first IP administration.
- History or presence of alcohol or drug abuse within the 1 year prior to the first IP administration, and unwillingness to be totally abstinent during the treatment period.
- Positive urine drug screen/alcohol breath test at Day -1 (admission). Repeat urine drug screens will be permitted for suspected false positive results.
- Intake of alcohol or caffeine-containing products from 48 hours before first IP administration through the EOS visit.
- Active smokers and users of nicotine-containing products. Note, participants must discontinue smoking/use of nicotine-containing products from 48 hours before first IP administration through the EOS visit.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pirfenidone & BLD-0409
Following an overnight fast, subjects will be administered IP in a fixed sequence.
|
Fixed sequence use of active product, TID
Fixed sequence use of active product, QD
|
Experimental: Nintedanib & BLD-0409
Following an overnight fast, subjects will be administered IP in a fixed sequence.
|
Fixed sequence use of active product, QD
Fixed sequence use of active product, BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum observed drug concentration (Cmax)
Time Frame: Up to 18 days
|
Estimated from plasma concentration
|
Up to 18 days
|
Time of the maximum drug concentration (Tmax)
Time Frame: Up to 18 days
|
Estimated from plasma concentration
|
Up to 18 days
|
Area under the drug concentration-time curve (AUC) as follows: Pirfenidone - AUC0-8 (Arm 1); Nintedanib - AUC0-12 (Arm 2); BLD-0409 - AUC0-24 (both arms).
Time Frame: Up to 18 days
|
Estimated from plasma concentration
|
Up to 18 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence, nature and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 18 days
|
Safety and tolerability will be assessed based on the incidence, nature and severity of TEAEs and SAEs, and changes in safety laboratories, vitals and ECGs
|
Up to 18 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kimberly S Cruz, MD, Advanced Pharma Cr, Llc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2021
Primary Completion (Actual)
December 16, 2021
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
June 17, 2021
First Submitted That Met QC Criteria
June 17, 2021
First Posted (Actual)
June 25, 2021
Study Record Updates
Last Update Posted (Actual)
April 15, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Pirfenidone
- Nintedanib
Other Study ID Numbers
- B-0409-104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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