Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers

NCT04939467 | Completed Phase 1 FDA Drug

• 1 other identifier: B-0409-104
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Drug Drug Interaction

Outcome Measures

Primary Outcomes (3)

• Maximum observed drug concentration (Cmax)

  Estimated from plasma concentration

  Up to 18 days

• Time of the maximum drug concentration (Tmax)

  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).

  Estimated from plasma concentration

  Up to 18 days

Secondary Outcomes (1)

• Incidence, nature and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs)

  Up to 18 days

Study Arms (2)

Pirfenidone & BLD-0409

EXPERIMENTAL

Following an overnight fast, subjects will be administered IP in a fixed sequence.

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.

Drug: Nintedanib 150 mg Oral Capsule; Drug: BLD-0409 750 mg Oral Tablet

Interventions

Pirfenidone 267 mg Oral Tablet DRUG

Fixed sequence use of active product, TID

Pirfenidone & BLD-0409

Nintedanib 150 mg Oral Capsule DRUG

Fixed sequence use of active product, BID

Nintedanib & BLD-0409

BLD-0409 750 mg Oral Tablet DRUG

Fixed sequence use of active product, QD

Nintedanib & BLD-0409; Pirfenidone & BLD-0409

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blade Therapeutics: lead

Study Sites (1)

Advanced Pharma

Miami, Florida, 33147, United States

Location

MeSH Terms

Interventions

pirfenidone; Tablets; nintedanib

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Kimberly S Cruz, MD

  Advanced Pharma CR, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: October 15, 2021
• Primary Completion: December 16, 2021
• Study Completion: April 1, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)