HealthyPhase 1NCT04372394
A Study to Assess the Effect of a High Fat Meal on Surufatinib in Healthy Subjects
A Phase 1 study testing surufatinib in people with Healthy, run by Hutchison Medipharma Limited at 1 site in United States.
Trial summary
This study will be a 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to either receive a single dose of surufatinib with food in period 1, then without food in period 2, or vice-versa. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- surufatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 2 Mar 2021
- 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
- Non-smoking, healthy male or female between the ages of 18 and 55 years old inclusive).
- Body mass index (BMI) > 18 and ≤ 29 kg/m2.
- Females must be of non-childbearing potential, or of childbearing potential and agree to use a medically acceptable method of contraception.
- Males who have not had a successful vasectomy and are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception starting for at least one menstrual cycle prior to and throughout the entire study period, and for 2 weeks after the last dose of study drug. Those with partners using hormonal contraceptives must also use an additional approved method of contraception. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
Who cannot join
- Evidence of clinically significant cardiovascular, hepatic, GI, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or had a known history of any GI surgery or cholecystectomy.
- Clinically significant illness within 8 weeks or had a clinically significant infection within 4 weeks prior to the first dose.
- Known food allergy to any content of the standard meal to be used in this study.
- Clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations.
- Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.
- The subject has a clinically significant ECG abnormality, or had a family history of prolonged QTc syndrome or sudden death.
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- A history of smoking or use of nicotine-containing substances within the previous 2 months.
- A history of drug or alcohol misuse in the previous 6 months.
- Has been diagnosed with acquired immune deficiency syndrome (AIDS) or are positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
- Has participated in a clinical trial of other drug before screening, and the time since the last use of other study drug is less than 5 times the half- life or 4 weeks, whichever is longer, or the subject is currently enrolled in another clinical trial.
- Has received blood or blood products within 4 weeks, or donated blood or blood products within 8 weeks.
- Has used any over-the-counter (OTC) medications or prescription drugs within 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Two Period Crossover Study to Assess the Effect of a High Fat Meal on the Pharmacokinetics of Surufatinib in Healthy Subjects
This study will be a 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to either receive a single dose of surufatinib with food in period 1, then without food in period 2, or vice-versa.
Read the detailed description
This study will be a single center, open label, randomized crossover, 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows:
- Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8
- Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8
- Conditions
- Healthy
- Being tested
- surufatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surufatinibDrug
Surufatinib: 300 mg as a single dose on Days 1 and 8 with or without food
| Study group | Role | What they receive |
|---|---|---|
| Fed/Fasted | Experimental | surufatinib with food on Day 1 and surufatinib without food on Day 8 Receives: Drug: surufatinib |
| Fasted/Fed | Experimental | surufatinib without food on Day 1 and surufatinib with food on Day 8 Receives: Drug: surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (0-t) of Surufatinib
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration
Measured: Up to Day 15
AUC of Surufatinib
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity
Measured: Up to Day 15
Cmax of Surufatinib
Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration
Measured: Up to Day 15
Secondary outcomes (1)
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
To evaluate the safety, in healthy subjects, of a single dose of surufatinib administered with and without food
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start14 Aug 2020
- Primary completion31 Oct 2020
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows: * Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8 * Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeanelle Kam, MD, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372394
- Sponsor's protocol ID
- 2019-012-00US1
- Status last verified
- Jul 2020
- First submitted
- 14 Apr 2020
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two Period Crossover Study to Assess the Effect of a High Fat Meal on the Pharmacokinetics of Surufatinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04372394
- Acronym / sponsor ID
- 2019-012-00US1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 4 May 2020 (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 study will be a 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to either receive a single dose of surufatinib with food in period 1, then without food in period 2, or vice-versa.
Detailed description
This study will be a single center, open label, randomized crossover, 2-period study conducted with 26 healthy male or female subjects. Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows:
- Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8
- Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to 1 of the 2 possible treatment sequences as follows: * Fed/Fasted: surufatinib with food on Day 1 and surufatinib without food on Day 8 * Fasting/Fed: surufatinib without food on Day 1 and surufatinib with food on Day 8
| Arm | Type | Receives |
|---|---|---|
| Fed/Fasted | Experimental | Drug: surufatinibsurufatinib with food on Day 1 and surufatinib without food on Day 8 |
| Fasted/Fed | Experimental | Drug: surufatinibsurufatinib without food on Day 1 and surufatinib with food on Day 8 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smoking, healthy male or female between the ages of 18 and 55 years old inclusive).
- Body mass index (BMI) > 18 and ≤ 29 kg/m2.
- Females must be of non-childbearing potential, or of childbearing potential and agree to use a medically acceptable method of contraception.
- Males who have not had a successful vasectomy and are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception starting for at least one menstrual cycle prior to and throughout the entire study period, and for 2 weeks after the last dose of study drug. Those with partners using hormonal contraceptives must also use an additional approved method of contraception. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation.
Key exclusion criteria (12 listed)
- Evidence of clinically significant cardiovascular, hepatic, GI, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or had a known history of any GI surgery or cholecystectomy.
- Clinically significant illness within 8 weeks or had a clinically significant infection within 4 weeks prior to the first dose.
- Known food allergy to any content of the standard meal to be used in this study.
- Clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations.
- Systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg.
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 |
|---|---|---|
| surufatinibSurufatinib: 300 mg as a single dose on Days 1 and 8 with or without food | Drug | Fasted/Fed, Fed/Fasted |
Primary outcome
AUC (0-t) of Surufatinib
Time frame: Up to Day 15
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration
AUC of Surufatinib
Time frame: Up to Day 15
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity
Cmax of Surufatinib
Time frame: Up to Day 15
Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration
1 secondary outcome
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Time frame: Up to Day 15
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 24 May 2021.
- Individual participant dataSharing planned: No
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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.
Jeanelle Kam, MD principal investigator
Covance Clinical Research Unit
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 surufatinib in people with Healthy, run by Hutchison Medipharma Limited 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 4 inclusion and 12 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 24 May 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 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?
AUC (0-t) of Surufatinib (time frame: Up to Day 15). 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?
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 24 May 2021.