Phase I Clinical Trial in Healthy Male Volunteers

NCT03860532 | Completed Phase 1 DMC

• 1 other identifier: 2009-011-00AU1
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  72 hours

• Steady State concentration of HMPL-011

  Steady State concentration of HMPL-011 will be caculated based on Ctrough

  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.

  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.

  72 hours

Secondary Outcomes (1)

• Overall incidence of TEAEs

  5 weeks

Study Arms (2)

HMPL-011 tablets

ACTIVE COMPARATOR

A sigle total oral dose of 1200 mg tablets (600 mg tablet X 2)

Drug: HMPL-011 tablets

HMPL-011 capsules

ACTIVE COMPARATOR

A sigle total oral dose of 1200 mg capsules (200 mg tablet X 6)

Drug: HMPL-011 capsules

Interventions

HMPL-011 tablets DRUG

Eligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance.

HMPL-011 tablets

HMPL-011 capsules DRUG

Eligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance.

HMPL-011 capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 4, 2019
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 5, 2019

Record last verified: 2019-03