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ADMEPhase 1NCT03525405

A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects

A Phase 1 study testing napabucasin in people with ADME and Healthy, run by Sumitomo Pharma America, Inc. at 1 site in United States.

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 I, single-center, open-label, single-sequence, study evaluating the absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a mixture 14C-radiolabeled and unlabeled material. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
ADME, Healthy
What is being tested?
napabucasin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
18 May 2018to 2 Jun 2018
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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
  • 2. Subject is male. 3. Subject is between the ages of 18 and 45 years, inclusive at screening. 4. Subject has a body mass index between 18 and 34 kg/m^2 (weight/[height]^2) inclusive at screening.
  • 5. Subject has normal (or abnormal and clinically insignificant according to the Investigator) laboratory values at screening. 6. Subject is in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, or clinical laboratory evaluations at Screening or Check-in Day -1 as assessed by the Investigator (or designee). Subject has the ability to understand the requirements of the study and a willingness to comply with all study procedures.
  • 7. Subject has not consumed and agrees to abstain from taking any dietary supplements, herbal products, and non-prescription drugs (except as authorized by the Investigator and Medical Monitor) for 14 days prior to clinical research unit (CRU) admission through follow-up call.
  • 8. Subject has not consumed and agrees to abstain from taking any prescription drugs (except as authorized by the Investigator and Medical Monitor) during the 14 days prior to CRU admission through follow-up call.
  • 9. Subject has not consumed alcohol-containing beverages for 3 days prior to CRU admission and agrees not to consume alcohol through clinic discharge. 10. Subject has not consumed char-broiled meats, cruciferous vegetables, and grapefruit-, apple-, or Seville orange-containing products within the 3 days prior to CRU admission and agrees not to consume Seville oranges, grapefruit and grapefruit juice through clinic discharge.
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  • 11. Subject has not used tobacco- and nicotine-containing products within 2 months prior to the CRU admission and agrees to abstain from using tobacco- and nicotine-containing products through clinic discharge.
  • 12. Subject agrees to abstain from consuming caffeine- or xanthine-containing products from 3 days prior to CRU admission through clinic discharge.
  • 13. History of a minimum of 1 bowel movement per day Exclusion criteria
  • Subject has a history of illicit drug abuse in the past year or displays current evidence of such abuse in the opinion of the Investigator.
  • Subject has positive findings on urine drug screen (including cotinine).
  • Subject is positive for human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C on Screening assessments.
  • Subject has a QTcF >450 msec at screening (confirmed by repeat).
  • Subject has a female partner who is either pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug, or unwilling to follow the contraception requirements.
  • Subject has a clinically significant acute illness within 1 week of CRU admission, or symptoms of active illness at check-in, at discretion of the Investigator (or designee).
  • Subject has a hypersensitivity or allergy to napabucasin or the ingredients of napabucasin, or other clinically significant allergies in the opinion of the Investigator.
  • Subject has donated plasma within 7 days of drug administration.
  • Subject has donated 1 or more pints of blood (or equivalent blood loss) within 30 days prior to drug administration.
  • Subject has a history of chronic Gastroesophageal reflux disease (GERD) or has used omeprazole or other proton pump inhibitors within 3 months of Screening.
  • Subject has congenital non-hemolytic hyperbilirubinemia [e.g., Gilbert's syndrome].
  • Subject has any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal tract surgery, except appendectomy).
  • Subject has participated in an investigational drug study within 30 days or 5 half-lives (whichever is longer) of exposure to another investigational medication prior to CRU admission.
  • Subject is an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, or a family member of the employees or the Investigator.
  • Subjects with exposure to significant diagnostic or therapeutic radiation (e.g., serial Xray, computed tomography scan, barium meal) or employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
  • Subjects who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase I, Open Label, Single Dose Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects

This is a Phase I, single-center, open-label, single-sequence, study evaluating the absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a mixture 14C-radiolabeled and unlabeled material.

Conditions
ADME, Healthy
Being tested
napabucasin

What participants receive

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

  • napabucasinDrug

    Also called BBI-608, BBI608

    Single 240 mg dose containing 100 μCi of 14C-napabucasin will be administered with 240 mL of water following an overnight fast.

Study groups in NCT03525405
Study groupRoleWhat they receive
Single DoseExperimentalNot described
Receives: Drug: napabucasin

What is being measured

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

  1. Pharmacokinetics for napabucasin and metabolites by assessing plasma concentration

    Measured: 1 week

  2. Pharmacokinetics for napabucasin and metabolites by assessing urinary concentration

    Measured: Up to 12 days

  3. Pharmacokinetics for napabucasin and metabolites by assessing fecal concentration

    Measured: Up to 12 days

Secondary outcomes (1)

  1. Number of Patients with Adverse Events

    Measured: 4 weeks

Timeline

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

  1. First posted15 May 2018
  2. Study start18 May 2018
  3. Primary completion2 Jun 2018
  4. Study completion2 Jun 2018

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
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525405
Sponsor's protocol ID
BBI608-104
Status last verified
Nov 2023
First submitted
30 Apr 2018
Last updated
8 Nov 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing napabucasin in people with ADME and Healthy, run by Sumitomo Pharma America, Inc. 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 25 inclusion and 0 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 8 Nov 2023. 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?

Pharmacokinetics for napabucasin and metabolites by assessing plasma concentration (time frame: 1 week). 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?

On the ClinicalTrials.gov record for NCT03525405.

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 8 Nov 2023.

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