The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects

NCT03502902 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PCD-DHEC68498-17-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the Pharmacokinetics of HEC68498 in Healthy Male and Female Subjects

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Adverse event

  To assess the safety and tolerability of single dose administered

  up to 4 weeks

Secondary Outcomes (6)

• AUC0-∞

  up to one week

• AUC0-t

  up to one week

• Cmax

  up to one week

• tmax

  up to one week

• t½

  up to one week

Study Arms (2)

HEC68498

EXPERIMENTAL

administered once on first day in each Treatment Period， HEC68498 VS placebo 3:1 ratio

Drug: HEC 68498

placebo

PLACEBO COMPARATOR

administered once on first day in each Treatment Period

Drug: Placebo

Interventions

HEC 68498 DRUG

HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.

HEC68498

Placebo DRUG

Placebo

placebo

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 signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is not acceptable) at Screening or Check-in as assessed by the Investigator (or designee).
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Section 6.6.
• Where doses exceed 10 mg or where the maximum systemic exposure for any individual subject is predicted to exceed that at the NOAEL of the male rat, male subjects must be sterile. For the purposes of this study, sterile male subjects will include those who have had a vasectomy performed at least 90 days prior to the screening visit and have documentation of azoospermia. Virile male subjects will include all males that do not meet the definition of sterile.
• Able to comprehend and willing to sign an 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).
• Fasting blood glucose \>110 mg/dL (confirmed with repeat testing).
• 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, including cholecystectomy, 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.
• Positive urine drug screen (including cotinine) at Screening or Check-in, or positive alcohol breath test at Check-in.
• Positive hepatitis panel and/or positive human immunodeficiency virus test.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing.
• Use or intend to use any prescription or nonprescription medications/products, including St. John抯 wort, vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 14 days prior to dosing,unless deemed acceptable by the Investigator (or designee).
• Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
• Unwilling or unable to abide by the dietary and exercise restrictions .
• Receipt of blood products within 2 months prior to Check-in.
• Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
• Poor peripheral venous access.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead
• Covance: collaborator

Study Sites (1)

Covance Clinical Research Unit, Inc.

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Irene Mirkin, MD

  Covance

  PRINCIPAL INVESTIGATOR

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: April 10, 2018
• First Posted: April 19, 2018
• Study Start: April 26, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)