Drug Drug InteractionPhase 1NCT04939467
Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers
A Phase 1 study testing Pirfenidone 267 mg Oral Tablet, Nintedanib 150 mg Oral Capsule and BLD-0409 750 mg Oral Tablet in people with Drug Drug Interaction, run by Blade Therapeutics at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- Pirfenidone 267 mg Oral Tablet, Nintedanib 150 mg Oral Capsule and BLD-0409 750 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 1 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Drug Drug Interaction
- Being tested
- Pirfenidone 267 mg Oral Tablet, Nintedanib 150 mg Oral Capsule, BLD-0409 750 mg Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone 267 mg Oral TabletDrug
Fixed sequence use of active product, TID
Nintedanib 150 mg Oral CapsuleDrug
Fixed sequence use of active product, BID
BLD-0409 750 mg Oral TabletDrug
Fixed sequence use of active product, QD
| Study group | Role | What they receive |
|---|---|---|
| Pirfenidone & BLD-0409 | Experimental | Following an overnight fast, subjects will be administered IP in a fixed sequence. Receives: Drug: Pirfenidone 267 mg Oral Tablet; Drug: BLD-0409 750 mg Oral Tablet |
| Nintedanib & BLD-0409 | Experimental | Following an overnight fast, subjects will be administered IP in a fixed sequence. Receives: Drug: Nintedanib 150 mg Oral Capsule; Drug: BLD-0409 750 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed drug concentration (Cmax)
Estimated from plasma concentration
Measured: Up to 18 days
Time of the maximum drug concentration (Tmax)
Estimated from plasma concentration
Measured: 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).
Estimated from plasma concentration
Measured: Up to 18 days
Secondary outcomes (1)
Incidence, nature and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs)
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
Measured: Up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start15 Oct 2021
- Primary completion16 Dec 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blade Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly S Cruz, MD, Principal investigator, Advanced Pharma CR, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939467
- Sponsor's protocol ID
- B-0409-104
- Status last verified
- Apr 2022
- First submitted
- 17 Jun 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04939467
- Acronym / sponsor ID
- B-0409-104
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Blade TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone & BLD-0409 | Experimental | Drug: Pirfenidone 267 mg Oral Tablet, Drug: BLD-0409 750 mg Oral TabletFollowing an overnight fast, subjects will be administered IP in a fixed sequence. |
| Nintedanib & BLD-0409 | Experimental | Drug: Nintedanib 150 mg Oral Capsule, Drug: BLD-0409 750 mg Oral TabletFollowing an overnight fast, subjects will be administered IP in a fixed sequence. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pirfenidone 267 mg Oral TabletFixed sequence use of active product, TID | Drug | Pirfenidone & BLD-0409 |
| Nintedanib 150 mg Oral CapsuleFixed sequence use of active product, BID | Drug | Nintedanib & BLD-0409 |
| BLD-0409 750 mg Oral TabletFixed sequence use of active product, QD | Drug | Nintedanib & BLD-0409, Pirfenidone & BLD-0409 |
Primary outcome
Maximum observed drug concentration (Cmax)
Time frame: Up to 18 days
Estimated from plasma concentration
Time of the maximum drug concentration (Tmax)
Time frame: Up to 18 days
Estimated from plasma concentration
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
1 secondary outcome
Incidence, nature and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 18 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly S Cruz, MD principal investigator
Advanced Pharma CR, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pirfenidone 267 mg Oral Tablet, Nintedanib 150 mg Oral Capsule and BLD-0409 750 mg Oral Tablet in people with Drug Drug Interaction, run by Blade Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed drug concentration (Cmax) (time frame: Up to 18 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.