Drug-drug InteractionsPhase 1NCT03411122
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers
A Phase 1 study testing napabucasin and cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate in people with Drug-drug Interactions, run by Sumitomo Pharma America, Inc. at 1 site in United States.
Trial summary
This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interactions
- What is being tested?
- napabucasin and cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2017to 23 Jan 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all the following criteria apply:
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Subject is between the ages of 18 and 45 years, inclusive.
- Subject is a female of childbearing potential with a negative pregnancy test or has documented surgical sterilization or is post-menopausal prior to Screening. All male and female subjects must agree to use contraception while participating in the study and for 30 days after their last dose of study drug unless surgically sterile or post-menopausal.. It is the Investigator's responsibility for determining whether the Subject has adequate birth control for study participation.
- Subject has a body mass index between 18 and 34 kg/m^2 (weight/[height]^2).
- Subject has normal (or abnormal and clinically insignificant according to the Investigator) laboratory values at screening.
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- Subject is medically normal with no significant abnormalities at the baseline physical examination.
- Subject has the ability to understand the requirements of the study and a willingness to comply with all study procedures.
- Subject has not consumed and agrees to abstain from taking any dietary supplements, herbal products, or non-prescription drugs (except as authorized by the Investigator and Medical Monitor) for 14 days prior to CRU admission through Follow-Up.
- 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.
- Subject has not consumed alcohol-containing beverages for 3 days prior to CRU admission and agrees not to consume alcohol through Follow-Up.
- Subject has not consumed grapefruit, grapefruit juice, Seville oranges, and grapefruit- or Seville orange containing products within the 14 days prior to CRU admission and agrees not to consume grapefruit or grapefruit juice through Follow-Up.
- 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 Follow-up.
- Subject agrees to abstain from consuming caffeine- or chocolate-containing products from 3 days prior to CRU admission through Follow-up.
Who cannot join
- A Subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Subject has a history illicit drug abuse in the past year or current evidence of such abuse in the opinion of the Investigator.
- Subject has positive findings on urine drug screen.
- Subject is positive for human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C on Screening assessments.
- Subject is determined to be a poor metabolizer for CYP2C19, CYP2C9 and/or CYP2D6.
- Subject has a QTcF >450 msec (if male) or >470 msec (if female) at Screening.
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- Subject is pregnant or lactating.
- Subject has an acute illness within 1 week of CRU admission.
- Subject has a hypersensitivity or allergy to napabucasin or any of the probe drugs, or the ingredients of napabucasin or any of the probe drugs, or other clinically significant allergies.
- 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 participated in an investigational drug study within the 30 days 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers
This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.
- Conditions
- Drug-drug Interactions
- Being tested
- napabucasin, cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate
- Keywords
- Enzyme Inhibitors, Cytochrome P-450 Enzyme Inducers
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
Napabucasin will be administered at dose of 240 mg twice daily, every 12 hours (BID) on days 1-2 in period 1, and on days 1-11 in period 3.
cytochrome P450 (CYP450) probe drugs or BCRP transporter substrateDrug
CYP450 probe drugs or BCRP transporter substrate will be administered once every period during days 1-4 in period 2, and days 6-9 in period 3.
| Study group | Role | What they receive |
|---|---|---|
| Single-sequence 3-period | Experimental | Period 1: napabucasin 240 mg BID on days 1-2 Period 2: cytochrome P450 probe drugs during days 1-4 Period 3: napabucasin 240 mg BID on days 1-11, cytochrome P450 probe drugs during days 6-9 Receives: Drug: napabucasin; Drug: cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics for napabucasin by assessing plasma concentration
Measured: Predose and up to 7 days post dose
Pharmacokinetics for probe drugs by assessing plasma concentration
Measured: Predose and up to 7 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start30 Jun 2017
- Primary completion23 Jan 2018
- Study completion23 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug-drug InteractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411122
- Sponsor's protocol ID
- BBI608-102
- Status last verified
- Nov 2023
- First submitted
- 19 Jan 2018
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Dai X, Karol MD, Hitron M, Hard ML, Goulet MT, McLaughlin CF, Brantley SJ. Napabucasin Drug-Drug Interaction Potential, Safety, Tolerability, and Pharmacokinetics Following Oral Dosing in Healthy Adult Volunteers. Clin Pharmacol Drug Dev. 2021 Aug;10(8):824-839. doi: 10.1002/cpdd.961. Epub 2021 Jun 9.
PubMed 34107166
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Drug Interaction Potential of Napabucasin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03411122
- Acronym / sponsor ID
- BBI608-102
- Conditions
- Drug-drug Interactions
- Keywords
- Enzyme Inhibitors, Cytochrome P-450 Enzyme Inducers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, single-center, open-label, single-sequence, 3-period, PK drug interaction study evaluating the effect of napabucasin in healthy volunteers on the single-dose PK of several cytochrome P450 (CYP450) probe drugs as well as a BCRP substrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-sequence 3-period | Experimental | Drug: napabucasin, Drug: cytochrome P450 (CYP450) probe drugs or BCRP transporter substratePeriod 1: napabucasin 240 mg BID on days 1-2 Period 2: cytochrome P450 probe drugs during days 1-4 Period 3: napabucasin 240 mg BID on days 1-11, cytochrome P450 probe drugs during days 6-9 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- A subject will be eligible for inclusion in this study only if all the following criteria apply:
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Subject is between the ages of 18 and 45 years, inclusive.
- Subject is a female of childbearing potential with a negative pregnancy test or has documented surgical sterilization or is post-menopausal prior to Screening. All male and female subjects must agree to use contraception while participating in the study and for 30 days after their last dose of study drug unless surgically sterile or post-menopausal.. It is the Investigator's responsibility for determining whether the Subject has adequate birth control for study participation.
- Subject has a body mass index between 18 and 34 kg/m^2 (weight/[height]^2).
Key exclusion criteria (14 listed)
- A Subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Subject has a history illicit drug abuse in the past year or current evidence of such abuse in the opinion of the Investigator.
- Subject has positive findings on urine drug screen.
- Subject is positive for human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C on Screening assessments.
- Subject is determined to be a poor metabolizer for CYP2C19, CYP2C9 and/or CYP2D6.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| napabucasinAlso: BBI-608, BBI608Napabucasin will be administered at dose of 240 mg twice daily, every 12 hours (BID) on days 1-2 in period 1, and on days 1-11 in period 3. | Drug | Single-sequence 3-period |
| cytochrome P450 (CYP450) probe drugs or BCRP transporter substrateCYP450 probe drugs or BCRP transporter substrate will be administered once every period during days 1-4 in period 2, and days 6-9 in period 3. | Drug | Single-sequence 3-period |
Primary outcome
Pharmacokinetics for napabucasin by assessing plasma concentration
Time frame: Predose and up to 7 days post dose
Pharmacokinetics for probe drugs by assessing plasma concentration
Time frame: Predose and up to 7 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 34107166Dai X, Karol MD, Hitron M, Hard ML, Goulet MT, McLaughlin CF, Brantley SJ. Napabucasin Drug-Drug Interaction Potential, Safety, Tolerability, and Pharmacokinetics Following Oral Dosing in Healthy Adult Volunteers. Clin Pharmacol Drug Dev. 2021 Aug;10(8):824-839. doi: 10.1002/cpdd.961. Epub 2021 Jun 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing napabucasin and cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate in people with Drug-drug Interactions, 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 14 inclusion and 14 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 14 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 by assessing plasma concentration (time frame: Predose and up to 7 days post dose). 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 NCT03411122, which also lists 1 linked publication.
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 14 Nov 2023.