Drug-Drug Interaction (DDI) Study in Healthy Volunteers

NCT04814498 | Completed Phase 1

• 1 other identifier: B-0409-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of BLD-0409 on the Single Dose Pharmacokinetics of a Cocktail of Probe Substrates for CYP450 Enzymes in Healthy Volunteers

Conditions

Drug Drug Interaction

Outcome Measures

Primary Outcomes (2)

• Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)

  Measured by plasma concentration of probe substrates

  Up to 16 days

• Maximum observed drug concentration (Cmax)

  Measured by plasma concentration of probe substrates

  Up to 16 days

Study Arms (1)

Geneva cocktail (less fexofenadine) & BLD-0409

EXPERIMENTAL

Following an overnight fast of at least 10 hours, subjects will be administered IP in a fixed sequence.

Drug: Geneva Cocktail; Drug: BLD-0409

Interventions

Geneva Cocktail DRUG

Fixed sequence use of drug cocktail

Geneva cocktail (less fexofenadine) & BLD-0409

BLD-0409 DRUG

Fixed sequence use of active product

Geneva cocktail (less fexofenadine) & BLD-0409

Eligibility Criteria

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

You may qualify if:

• Provide signed informed consent prior to study entry.
• Males and females aged 18 to 55 years at the time of consent.
• Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
• Agree to abstain from alcohol intake from 48 hours before first IP administration through to discharge from the CRU.
• Agree to abstain from all caffeine- and xanthine-containing products (e.g., coffee, tea, cola drinks, chocolate) for 48 hours before first IP administration through to discharge from the CRU.
• Have a negative urine drug screen/alcohol breath test at Day -1 (Admission). Repeat urine drug screens will be permitted for suspected false positive results.
• Use of acceptable contraception.
• Males must not donate sperm for at least 90 days after the last dose of study drug.
• Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test on Day -1. If a urine test is conducted and it is positive, a serum pregnancy test must also be performed for confirmation. Females not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle-stimulating hormone (FSH) level \> 40 mIU/mL at Screening.
• In good general health, in the opinion of the Principal Investigator (PI), with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of study drug.
• Have clinical laboratory values within normal ranges.

You may not qualify if:

• Active smoker and/or user of nicotine-containing products (i.e., have not used nicotine-containing products within the previous 3 months).
• Human immunodeficiency virus (HIV) antibody positive.
• Hepatitis B surface antigen (HBsAg) positive or Hepatitis C virus (HCV) positive.
• Presence of any underlying or clinically significant physical or psychological medical condition (e.g., hypertension, elevated cholesterol/triglycerides, asthma, or diabetes) that, in the opinion of the PI, would make it unlikely that the subject will complete the study per protocol.
• History or presence of alcohol or drug abuse (including recreational marijuana use) within the 2 years prior to the first IP administration, and unwillingness to be totally abstinent during the period of confinement.
• Blood donation or significant blood loss within 30 days prior to the first study drug administration.
• Plasma donation within 7 days prior to the first study drug administration.
• Administration of IP in another trial within 30 days prior to the first IP administration, or 5 half-lives, whichever is longer.
• Females who are pregnant or breastfeeding.
• Surgery within the past 3 months prior to the first IP administration determined by the PI to be clinically relevant.
• Consumption of any nutrients known to modulate cytochrome P450 3A4 (CYP3A4) or any strong inhibitors or inducers of CYP3A4, starting from 14 days prior to the first dose of IP on Day 1 and until the EOS assessments.
• Consumption of cruciferous vegetables or chargrilled meat more than 3 × per week in the previous 2 weeks.
• Inability to refrain from consumption of grapefruit and Seville oranges or St. John's Wort within 14 days prior to the first dose of IP on Day 1 and until the EOS assessments.
• Failure to satisfy the PI of fitness to participate for any other reason.
• Active infection (diagnosed or suspected) or history of recurrent infections.

Sponsors & Collaborators

• Blade Therapeutics: lead

Study Sites (1)

Nucleus Network Pty Ltd.

Herston, Queensland, 4006, Australia

Location

Study Officials

• Kristi McLendon, MD

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: May 3, 2021
• Primary Completion: September 17, 2021
• Study Completion: January 11, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)