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Healthy VolunteersPhase 1NCT04098692

Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects

A Phase 1 study testing Derazantinib capsule, [14C]-Derazantinib solution for infusion and [14C]-Derazantinib capsule in people with Healthy Volunteers, run by Basilea Pharmaceutica at 1 site in United Kingdom.

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

This is a Phase 1, two-part, open-label, single centre, single arm study in healthy male subjects to investigate the oral PK, intravenous (IV) PK, mass balance, bioavailability and metabolites profiling and identification of derazantinib. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Derazantinib capsule, [14C]-Derazantinib solution for infusion and [14C]-Derazantinib capsule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
8 Aug 2019to 18 Nov 2019
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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males
  • Age 18 to ≤ 55 years (Part 1)
  • Age 30 to ≤ 65 years (Part 2)
  • Body mass index of 18.0 to 29.0 kg/m² and a minimum body weight of 50 kg
  • Must have regular bowel movements
  • Must agree to adhere to the contraception requirements

Who cannot join

  • Male subjects with pregnant partners
  • Subjects who have received any investigational medicine in a clinical research study within the previous 3 months
  • Subjects who are study site employees, or immediate family members of a study site or sponsor employee
  • History of any drug or alcohol abuse in the 12 months prior to dosing
  • Regular alcohol consumption in males > 21 units per week
  • Smokers and users of e-cigarettes and nicotine replacement products and those who have used these products within the last 3 months
Show all 29Show fewer
  • Radiation exposure (diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
  • Participation in any study involving administration of any [14C]-labelled compound within 12 months prior to screening (Part 1 only)
  • Excessive caffeine consumption within 14 days prior to screening, defined as 800 mg per day (approximately 6 large cups of coffee)
  • Subjects who do not have suitable veins
  • Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the Investigator
  • Confirmed positive drugs of abuse test result
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results, or history of immunodeficiency diseases, including a positive HIV (ELISA and western blot) test result
  • Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of < 70 mL/min using the Cockcroft-Gault equation
  • History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder or current clinical evidence of any corneal or retinal disorder
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
  • Known hypersensitivity or allergy to natural rubber latex
  • History of any food allergies
  • History of clinically significant ECG abnormalities
  • Familial history of sick-sinus syndrome
  • Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction
  • Recent (within the last 3 years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma disease, treated or not treated)
  • History of malignancy of any organ system (other than localised basal cell carcinoma of the skin), treated or untreated, within the past 5 years
  • Use of any prescription drugs (including vaccines), herbal supplements (such as St. John's Wort, homeopathic preparations), within 4 weeks prior to initial dosing, and/or over-the-counter medication, dietary supplements (vitamins and minerals included) within 2 weeks prior to initial dosing
  • Donation or loss of 400 mL or more of blood and/or plasma within 3 months prior to initial dosing
  • Any history or presence of frequent episodes of diarrhoea (defined as an increase of 4 to 6 stools per day over usual individual defecation pattern).
  • Significant illness within 2 weeks prior to initial dosing
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardise the subject in case of participation in the study.
  • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Sciences, Ruddington

    Nottingham

Other trials in United Kingdom

About this study

Official title: A Phase 1, Two-part, Open-label, Single-oral-dose Study to Investigate the Absolute Bioavailability and Absorption, Pharmacokinetics, Distribution, Metabolism, and Excretion of [14C]-Derazantinib in Healthy Male Subjects

This is a Phase 1, two-part, open-label, single centre, single arm study in healthy male subjects to investigate the oral PK, intravenous (IV) PK, mass balance, bioavailability and metabolites profiling and identification of derazantinib.

Being tested
Derazantinib capsule, [14C]-Derazantinib solution for infusion, [14C]-Derazantinib capsule

What participants receive

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

  • Derazantinib capsuleDrug

    300 mg derazantinib oral administration (3x100 mg capsules)

  • [14C]-Derazantinib solution for infusionDrug

    100 μg [14C]-derazantinib intravenous administration

  • [14C]-Derazantinib capsuleDrug

    300 mg [14C]-derazantinib oral administration (3x100 mg capsules)

Study groups in NCT04098692
Study groupRoleWhat they receive
Single-Arm: Derazantinib (Part 1 and Part 2)Experimental* Part 1: 300 mg Derazantinib oral administration followed by 100 μg [14C]-Derazantinib intravenous microdose * Part 2: 300 mg [14C]-Derazantinib oral administration
Receives: Drug: Derazantinib capsule; Drug: [14C]-Derazantinib solution for infusion; Drug: [14C]-Derazantinib capsule

What is being measured

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

  1. Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: Cmax

    Assessment of the maximum observed plasma concentration (Cmax)

    Measured: up to Day 50

  2. Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: Tmax

    Assessment of the time from dosing at which Cmax was apparent (Tmax)

    Measured: up to Day 50

  3. Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: t½

    Assessment of the apparent terminal elimination half-life (t½)

    Measured: up to Day 50

  4. Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: AUC0-t

    Assessment of the area under the concentration-time curve from dosing to the last measurable concentration (AUC0-t)

    Measured: up to Day 50

  5. Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: AUC0-inf

    Assessment of the area under the concentration-time curve from dosing extrapolated to infinity (AUC0-inf)

    Measured: up to Day 50

  6. Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: Tlast

    Assessment of the time of the last measurable (positive) concentration (Tlast)

    Measured: up to Day 50

  7. Assessment of the PK of [14C]-derazantinib: CL

    Assessment of the total clearance (CL)

    Measured: up to Day 50

  8. Assessment of the PK of [14C]-derazantinib: Vss

    Assessment of the volume of distribution at steady state (Vss)

    Measured: up to Day 50

  9. Assessment of the PK of [14C]-derazantinib: Vd

    Assessment of the volume of distribution (Vd)

    Measured: up to Day 50

  10. Assessment of the PK of derazantinib: CL/F

    Apparent total clearance (CL/F)

    Measured: up to Day 50

  11. Assessment of the PK of derazantinib: F

    Absolute bioavailability (F)

    Measured: up to Day 50

  12. Assessment of the rate and routes of excretion, and the mass balance of total radioactivity in urine and faeces and in all excreta

    Assessment of total radioactivity by measuring the amount excreted (Ae), Ae as a percentage of the administered dose (%Ae), cumulative recovery (CumAe), and cumulative recovery expressed as a percentage of the dose (Cum%Ae)

    Measured: up to Day 50

Timeline

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

  1. First posted23 Sep 2019
  2. Study start8 Aug 2019
  3. Primary completion18 Nov 2019
  4. Study completion18 Nov 2019

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04098692
Sponsor's protocol ID
DZB-CS-102
Status last verified
Jan 2021
First submitted
19 Sep 2019
Last updated
19 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Derazantinib capsule, [14C]-Derazantinib solution for infusion and [14C]-Derazantinib capsule in people with Healthy Volunteers, run by Basilea Pharmaceutica at 1 site in United Kingdom.

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 6 inclusion and 29 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 19 Jan 2021. 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 Kingdom. 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?

Assessment of the PK of total radioactivity, [14C]-derazantinib, derazantinib, and BAL0122840: Cmax (time frame: up to Day 50). The study lists 12 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 NCT04098692.

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 19 Jan 2021.

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