Inflammatory Bowel DiseasesPhase 1NCT03860532
Phase I Clinical Trial in Healthy Male Volunteers
A Phase 1 study testing HMPL-011 tablets and HMPL-011 capsules in people with Inflammatory Bowel Diseases, run by Hutchison Medipharma Limited.
Trial summary
This is a Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- HMPL-011 tablets and HMPL-011 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2011
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the study:
- Healthy adult male and female subjects, 18-70 years of age, inclusive, at the time of signing the informed consent;
- Body weight ≥ 50 kg and body mass index (BMI) within the range 19-30 kg/m2, inclusive, at screening;
- Medically healthy subjects with clinically insignificant screening and check-in results (medical histories, 12-lead ECG, physical exam and laboratory tests);
- Female subjects of childbearing potential with a negative urine pregnancy test at screening who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control from the first dose until 7 days following the last administration of study drug;
- Male subjects must agree to use barrier contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) from first dose until 7 days following the last administration of study drug; and
- Subjects are able to understand and to give their signed informed consent before any trial related procedures being performed.
Who cannot join
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Subjects with, or a history of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric or other major disorder;
- Presence or history of GI, hepatic or renal disease or any other condition (including surgery) known to interfere with the absorption, distribution, metabolism or excretion of medicines; Hutchison MediPharma Ltd. Clinical Study Protocol HMPL-004-1002 Confidential \& Proprietary 27 Final 20 July 2011
- Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 bpm after one repeat at screening or check-in;
- Abnormal ECGs at screening
- History of clinically significant drug and/or food allergies as determined by the Principal Investigator (PI);
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- Subjects will be excluded if they experience arrhythmia of any clinical significance;
- Subject is not willing to abstain from alcohol for 48 hours prior to the start of the first dose until completion of the post-study follow-up assessments;
- Any history (within 2 years) or current diagnosed alcoholism defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.);
- Recent history or current diagnosed drug abuse;
- Tobacco or nicotine use within the 6 months prior to first dose until the follow-up assessment, or a positive urine screen for cotinine;
- Hypersensitivity or idiosyncratic reaction to compounds related to the study drug;
- Use of substances known to be strong inhibitors or inducers of cytochrome P450 enzymes (eg, macrolides, calcium channel blockers, ritonavir, rifampin, St. John's Wort, etc.) within 30 days prior to the first dose;
- Use of prescription or non-prescription drugs, including high-dose vitamins, herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication (except for strong inhibitors or inducers of cytochrome P450 enzymes);
- Consumption of food or beverage containing grapefruit or cranberry within 7 days prior to the dose of study medication;
- Recent significant changes in body weight due to dieting or nutritional treatment;
- Donation of whole blood in excess of 500 mL within 56 days prior to checkin;
- Plasma donation within 7 days prior to check-in;
- Subject participated in an investigational clinical study within 30 days prior to the first dosing, or days calculated as ten times the half-life of the compound which the subject was treated with, whichever is longer. Factors other than the half-life of the compound, such as accumulation of tissue, muscle or organ, should also be considered for the enrollment;
- Exposure to 4 or more investigational products within 12 months prior to the first dosing day; Hutchison MediPharma Ltd. Clinical Study Protocol HMPL-004-1002 Confidential \& Proprietary 28 Final 20 July 2011
- Positive screen for HIV, hepatitis B, and/or hepatitis C at screening;
- Positive urine screen for drugs of abuse at screening or check-in; and
- Any condition that, in the opinion of the Principal Investigator, would complicate or compromise the study, or the well-being of the subject 4.2.3 General and Dietary Restrictions
- The following items are not to be consumed for 48 hours (2 days) prior to the first dose until the last scheduled blood sample collection of the study:
- Caffeine/xanthine such as coffee, tea, chocolate, and all caffeine containing soft drinks or energy drinks;
- Alcoholic beverages and/or other alcohol containing products; and
- Any foods containing poppy seeds.
- The following items are not to be consumed for 14 days prior to the first dose and throughout the study until the last scheduled blood sample collection:
- Grapefruit, pomelo, cranberry, or grapefruit, pomelo, or cranberry-containing products. While in the CPU, subjects will not be allowed additional sugar in beverages or on cereal, though limited use of other sweeteners is allowed.
About this study
Official title: Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.
This is a Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.
Read the detailed description
Eligible subjects will randomly recieve 1200 mg tablets (600 mg tablet X 2) or 1200 mg capsules (200 mg capsule X 6) of HMPL-011 under fed and fed circumstance in part 1. In part 2, eight subjects will be enrolled and given 800 mg tablets (400 mg/tablet X 2) every 8 hours daily for 6 days (morning dose only on Day 6).
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- HMPL-011 tablets, HMPL-011 capsules
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-011 tabletsDrug
Eligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance.
HMPL-011 capsulesDrug
Eligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance.
| Study group | Role | What they receive |
|---|---|---|
| HMPL-011 tablets | Active comparator | A sigle total oral dose of 1200 mg tablets (600 mg tablet X 2) Receives: Drug: HMPL-011 tablets |
| HMPL-011 capsules | Active comparator | A sigle total oral dose of 1200 mg capsules (200 mg tablet X 6) Receives: Drug: HMPL-011 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fasted States
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
Measured: 72 hours
Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fed States
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Measured: 72 hours
Steady State concentration of HMPL-011
Steady State concentration of HMPL-011 will be caculated based on Ctrough
Measured: 5 weeks
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets vs capsules in fed States.
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Measured: 72 hours
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets vs capsules in fasted States.
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
Measured: 72 hours
Secondary outcomes (1)
Overall incidence of TEAEs
The proportion of subjects reported at least 1 TEAE
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860532
- Sponsor's protocol ID
- 2009-011-00AU1
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2012
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.
- ClinicalTrials.gov ID
- NCT03860532
- Acronym / sponsor ID
- 2009-011-00AU1
- Conditions
- Inflammatory Bowel Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Mar 2019 (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 Randomized,Double-Blind,Placebo-controlled Trial in Healthy Male Voluteers To Examine the Safety,Tolerability,and Pharmacokinetics of HMPL-011 After A Single Dose.
Detailed description
Eligible subjects will randomly recieve 1200 mg tablets (600 mg tablet X 2) or 1200 mg capsules (200 mg capsule X 6) of HMPL-011 under fed and fed circumstance in part 1. In part 2, eight subjects will be enrolled and given 800 mg tablets (400 mg/tablet X 2) every 8 hours daily for 6 days (morning dose only on Day 6).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMPL-011 tablets | Active comparator | Drug: HMPL-011 tabletsA sigle total oral dose of 1200 mg tablets (600 mg tablet X 2) |
| HMPL-011 capsules | Active comparator | Drug: HMPL-011 capsulesA sigle total oral dose of 1200 mg capsules (200 mg tablet X 6) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the study:
- Healthy adult male and female subjects, 18-70 years of age, inclusive, at the time of signing the informed consent;
- Body weight ≥ 50 kg and body mass index (BMI) within the range 19-30 kg/m2, inclusive, at screening;
- Medically healthy subjects with clinically insignificant screening and check-in results (medical histories, 12-lead ECG, physical exam and laboratory tests);
- Female subjects of childbearing potential with a negative urine pregnancy test at screening who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control from the first dose until 7 days following the last administration of study drug;
Key exclusion criteria (29 listed)
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Subjects with, or a history of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric or other major disorder;
- Presence or history of GI, hepatic or renal disease or any other condition (including surgery) known to interfere with the absorption, distribution, metabolism or excretion of medicines; Hutchison MediPharma Ltd. Clinical Study Protocol HMPL-004-1002 Confidential \& Proprietary 27 Final 20 July 2011
- Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 bpm after one repeat at screening or check-in;
- Abnormal ECGs at screening
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 |
|---|---|---|
| HMPL-011 tabletsEligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance. | Drug | HMPL-011 tablets |
| HMPL-011 capsulesEligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance. | Drug | HMPL-011 capsules |
Primary outcome
Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fasted States
Time frame: 72 hours
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fed States
Time frame: 72 hours
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Steady State concentration of HMPL-011
Time frame: 5 weeks
Steady State concentration of HMPL-011 will be caculated based on Ctrough
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets vs capsules in fed States.
Time frame: 72 hours
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets vs capsules in fasted States.
Time frame: 72 hours
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
1 secondary outcome
Overall incidence of TEAEs
Time frame: 5 weeks
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 5 Mar 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMPL-011 tablets and HMPL-011 capsules in people with Inflammatory Bowel Diseases, run by Hutchison Medipharma Limited.
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 7 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fasted States (time frame: 72 hours). The study lists 5 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 5 Mar 2019.