- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203811
A Phase 1, Study to Evaluate HTI-2088 Tablet
November 10, 2017 updated by: Hengrui Therapeutics, Inc.
A Phase 1, Double-blind, Placebo-Controlled, Single Oral Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTI-2088 Tablet in Healthy Adult Subjects
Single Center, Randomized, Double Blind, Placebo Controlled, Single ascending dose trial at 3 levels.
Ten subjects will be enrolled at each dose.
Study Overview
Detailed Description
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose trial with single oral doses of HTI-2088 tablets to subjects at 3 levels (2.5, 3.75, 5 mg).
Ten subjects will be enrolled at each dose level, randomized within groups at an active: placebo ratio of 4:1.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45227
- Medpace
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female between 18 and 55 years of age (inclusive), without diabetes FPG <126 mg/dL.
- Body mass index (BMI) of 19 to 30 kg/m2 (inclusive); and a total body weight ≥50 kg.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- An informed consent document signed and dated by the subject.
- Male subjects must agree to utilize a highly effective method of contraception (condom with or without spermicide) during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 90 days following IP dosing, and must agree to refrain from sperm donation from Day 0 until at least 90 days after the IP dose.
Females must meet at least one of the following criteria:
- sexually inactive (abstinent) for at least 14 days prior to the first dose, throughout the study and for 90 days after IP dose
- postmenopausal, defined by at least 12 consecutive months of amenorrhea without an alternative medical cause
- using one of the following acceptable birth control methods: surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) at least 6 months prior to the first dose; intra-uterine device in place for at least 3 months prior to the first dose; barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study and for 90 days after IP dose; surgical sterilization of the partner (vasectomy for at least 6 months prior to the first dose); hormonal contraception for at least 3 months prior to the first dose, throughout the study and for 90 days after IP dose.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or drug allergies. In particular, any history or evidence at Screening of chronic GI disorders (e.g., celiac sprue, ulcerative colitis, Crohn's disease, etc.), thyroid disease, or pancreatitis, any condition possibly affecting drug absorption (e.g., gastrectomy).
- History of gastrointestinal surgery within one year of the screening visit.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that could have increased the risk associated with study participation or investigational product administration or could have interfered with the interpretation of study results and, in the judgment of the investigator, made the subject inappropriate for entry into the study.
- Positive results of alcohol or substances of abuse at screening or upon admission to the clinical research unit.
- A positive pregnancy test at screening and upon admission to the clinical research unit, or subject is lactating, if the subject is female.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounce (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening; Consumption of alcohol within 24 hours of receiving IP.
- Treatment with any investigational drug within 30 days or 5 half-lives preceding the first dose of IP.
- Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
- Blood donation of approximately 1 pint (approximately 473 mL) or more within 56 days, or plasma donation within 7 days of receiving IP.
- Use of prescription, nonprescription drugs, illicit drug use, and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of IP. Herbal supplements and hormone replacement therapy should be discontinued 28 days prior to the first dose of IP.
- Evidence of human immunodeficiency virus (HIV)/ hepatitis C/ hepatitis B infection and/or positive human HIV/hepatitis C/hepatitis B antibodies (a negative test result within the 3 months prior to screening may be used instead of obtaining a screening laboratory sample for these laboratory tests)
- History of using GLP-1 analogs.
- Known sensitivity to any of the components of the investigational product formulation or SNAC
- Current smoker or user of any tobacco products.
- Consumption of any grapefruit or grapefruit-containing juices within 14 days of receiving the IP.
- Consumption of any caffeine- or xanthine-containing foods or beverages within 24 hours of receiving IP.
- Have poor venous access and are unable to donate blood.
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
- Subjects who are investigational site staff members or subjects who are Sponsor employees directly involved in the conduct of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low Dose
2mg, HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days
|
3 dose levels
placebo oral tablet
|
EXPERIMENTAL: Middle Dose
3.75mg HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days
|
3 dose levels
placebo oral tablet
|
EXPERIMENTAL: High Dose
5mg HTI-2088 oral tablet or placebo, one dose, evaluate over 4 days
|
3 dose levels
placebo oral tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 1 week
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
|
1 week
|
Cmax
Time Frame: 1 week
|
Peak Plasma Concentration (Cmax)
|
1 week
|
AUC
Time Frame: 1 Week
|
Area under the plasma concentration versus time curve (AUC)
|
1 Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PD Effects
Time Frame: 1 week
|
effects on Glucose, Insulin, Insulin C-peptide
|
1 week
|
Glucose
Time Frame: 1 week
|
Number of patients with effects on Glucose, Insulin, Insulin C-peptide
|
1 week
|
Insulin
Time Frame: 1 week
|
Number of patients with effects on Insulin and Insulin C-peptide
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 17, 2017
Primary Completion (ACTUAL)
October 23, 2017
Study Completion (ACTUAL)
October 23, 2017
Study Registration Dates
First Submitted
June 12, 2017
First Submitted That Met QC Criteria
June 28, 2017
First Posted (ACTUAL)
June 29, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 14, 2017
Last Update Submitted That Met QC Criteria
November 10, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HTI-2088-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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