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Drug Drug InteractionPhase 1NCT04814498

Drug-Drug Interaction (DDI) Study in Healthy Volunteers

A Phase 1 study testing Geneva Cocktail and BLD-0409 in people with Drug Drug Interaction, run by Blade Therapeutics at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 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?
Geneva Cocktail and BLD-0409
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteAustralia
Study dates
3 May 2021to 11 Jan 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

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Active malignancy and/or history of malignancy in the past 5 years, except for completely excised non-melanoma skin carcinomas or low grade cervical intraepithelial neoplasia.
  • Serious local infection or systemic infection within 3 months requiring antibiotic treatment.
  • Any acute illness within 30 days prior to Day 1.
  • Use of any prescription or over-the-counter (OTC) medication (except for paracetamol and approved contraceptives) within 5 days or 5 half-lives (whichever is longer) prior to dosing and during course of study without prior approval of the Investigator and Medical Monitor. Simple analgesia (paracetamol) may be permitted at the discretion of the Investigator.
  • For all participants, the use of any estrogen-containing products (e.g., contraceptives, patch, cream, implants) within 14 days prior to the first study drug administration and until the EOS assessments.
  • Inability to refrain from vaccinations within 14 days of the first dose of IP and until the EOS assessments.
  • History of allergy or intolerance to any IP or IP constituents used on study or any clinically significant drug allergy as per the PIs judgment.
  • History of anaphylaxis or other severe allergic reaction to drug, food, toxin, or other exposure.
  • Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the IP.
  • Any evidence of cardiac disease or clinically significant abnormalities on ECG.
  • Systolic blood pressure (BP) > 150 mmHg or < 80 mmHg or diastolic BP > 90 mmHg or < 50 mmHg at Screening with one repeat allowed per the PIs discretion at Screening and Day -1.
  • Heart rate < 40 bpm or > 100 bpm at Screening with one repeat allowed per the PIs discretion at Screening and Day -1.
  • Diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.) within 7 days prior to dosing on Day 1.
  • Weight loss or gain of ≥ 10% in the 30 days prior to dosing.
  • Strenuous exercise, including weightlifting, (> 5 × per week) within 2 weeks prior to first IP administration on Day 1.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network Pty Ltd.

    Herston, Queensland, 4006

Other trials in Australia

About this study

Official title: 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

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

Read the detailed description

This is a single center, open label study designed to determine the effect of BLD-0409 on the PK of probe substrates and to evaluate the safety and tolerability of BLD-0409 administered alone and co-administered with a cocktail of probe substrates (i.e., Geneva cocktail less fexofenadine) in healthy adult volunteers.

Geneva Cocktail (Less Fexofenadine):

  • CYP1A2 Caffeine 50 mg
  • CYP2C Flurbiprofen 10 mg
  • CYP2C19 Omeprazole 10 mg
  • CYP2D6 Dextromethorphan 10 mg
  • CYP3A4 Midazolam 1 mg
  • CYP2B6 Bupropion 20 mg
Being tested
Geneva Cocktail, BLD-0409

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Geneva CocktailDrug

    Fixed sequence use of drug cocktail

  • BLD-0409Drug

    Fixed sequence use of active product

Study groups in NCT04814498
Study groupRoleWhat they receive
Geneva cocktail (less fexofenadine) & BLD-0409ExperimentalFollowing an overnight fast of at least 10 hours, subjects will be administered IP in a fixed sequence.
Receives: Drug: Geneva Cocktail; Drug: BLD-0409

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured by plasma concentration of probe substrates

    Measured: Up to 16 days

  2. Maximum observed drug concentration (Cmax)

    Measured by plasma concentration of probe substrates

    Measured: Up to 16 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start3 May 2021
  3. Primary completion17 Sep 2021
  4. Study completion11 Jan 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04814498
Sponsor's protocol ID
B-0409-103
Status last verified
May 2022
First submitted
22 Mar 2021
Last updated
17 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Geneva Cocktail and BLD-0409 in people with Drug Drug Interaction, run by Blade Therapeutics at 1 site in Australia.

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 11 inclusion and 30 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 17 May 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 Australia. 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?

Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) (time frame: Up to 16 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04814498.

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 17 May 2022.

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