The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects

NCT03092102 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PCD-DHEC585-16-001
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment drug HEC585 in Healthy Male and Female Subjects

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (6)

• Cmax

  Geometric Mean of Maximum Observed Plasma Concentration of HEC585

  Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h

• (AUC0-∞）

  area under the plasma concentration-time curve (AUC) from time zero to infinity

  Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h

• tmax

  time of the maximum observed plasma concentration

  Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h

• Vz/F

  apparent volume of distribution

  Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h

• t½

  apparent terminal elimination half-life

  Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h

• CL/F

  apparent oral clearance

  Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h

Secondary Outcomes (1)

• Adverse event

  From baseline to 7 days

Study Arms (14)

A single dose HEC585（A1）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

A single dose HEC585（A2）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

A single dose HEC585/FE（A3）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Treatment Period 1：No food prior to dosing；Treatment Period 2：High-fat meal prior to dosing

Drug: HEC585

A single dose HEC585（A4）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

A single dose HEC585（A5）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

A single dose HEC585（A6）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

A single dose HEC585（A7）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

A single dose HEC585（A8）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

Multiple doses HEC585（B1）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

Multiple doses HEC585（B2）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

Multiple doses HEC585（B3）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

Multiple doses HEC585（B4）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

Multiple doses HEC585（B5）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

Multiple doses HEC585（B6）

EXPERIMENTAL

Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule

Drug: HEC585

Interventions

HEC585 DRUG

HEC585, a pyrimidone compound, is structurally related to pirfenidone, a pyridine compound.

A single dose HEC585/FE（A3）; A single dose HEC585（A1）; A single dose HEC585（A2）; A single dose HEC585（A4）; A single dose HEC585（A5）; A single dose HEC585（A6）; A single dose HEC585（A7）; A single dose HEC585（A8）; Multiple doses HEC585（B1）; Multiple doses HEC585（B2）; Multiple doses HEC585（B3）; Multiple doses HEC585（B4）; Multiple doses HEC585（B5）; Multiple doses HEC585（B6）

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is not acceptable) at Screening and/or Check-in as assessed by the Investigator (or designee).
• Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception.
• Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
• History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
• Alcohol consumption of \> 21 units per week for males and \> 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in.
• Positive urine drugs of abuse screen including cotinine at Screening or Check-in.
• Positive hepatitis B surface antigen, hepatitis C virus antibody and/or positive human immunodeficiency virus (HIV) test (Appendix 3).
• Absolute lymphocyte count below the lower limit of normal which can be confirmed by repeat.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to Check-in.
• Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee). Strong CYP3A inhibitors and inducers should be avoided.
• Use or intend to use any prescription medications/products, within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
• Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
• Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville oranges within 7 days prior to Check-in, consumption of caffeine-containing foods and beverages within 72 hours prior to Check-in, or consumption of alcohol within 48 hours prior to Check-in.
• Receipt of blood products within 2 months prior to Check-in.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 35756, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: May 20, 2017
• Primary Completion: February 25, 2019
• Study Completion: February 25, 2019
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)