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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT03502902
• Date of registration: 10/04/2018
• Prospective Registration: Yes
• Primary sponsor: Sunshine Lake Pharma Co., Ltd.
• Public title: The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects
• Scientific title: 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
• Date of first enrolment: April 26, 2018
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03502902
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Irene Mirkin, MD
• Affiliation: Covance

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males or females, of any race, between 18 and 60 years of age, inclusive, at
Screening.

2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.

3. 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).

4. 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.

5. 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.

6. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

1. 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).

2. Fasting blood glucose >110 mg/dL (confirmed with repeat testing).

3. History of significant hypersensitivity, intolerance, or allergy to any drug compound,
food, or other substance, unless approved by the Investigator (or designee).

4. 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).

5. History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.

6. 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.

7. Positive urine drug screen (including cotinine) at Screening or Check-in, or positive
alcohol breath test at Check-in.

8. Positive hepatitis panel and/or positive human immunodeficiency virus test.

9. Participation in a clinical study involving administration of an investigational drug
(new chemical entity) in the past 30 days prior to dosing.

10. Use or intend to use any prescription or nonprescription medications/products,
including St. John? wort, vitamins, minerals, and
phytotherapeutic/herbal/plant-derived preparations within 14 days prior to
dosing,unless deemed acceptable by the Investigator (or designee).

11. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.

12. Unwilling or unable to abide by the dietary and exercise restrictions .

13. Receipt of blood products within 2 months prior to Check-in.

14. Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to
Screening, or platelets from 6 weeks prior to Screening.

15. Poor peripheral venous access.

16. Have previously completed or withdrawn from this study or any other study
investigating HEC68498, and have previously received the investigational product.

17. Subjects who, in the opinion of the Investigator (or designee), should not participate
in this study.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: HEC 68498

Drug: Placebo

Primary Outcome(s)

Adverse event [Time Frame: up to 4 weeks]

Secondary Outcome(s)

tmax [Time Frame: up to one week]

t½ [Time Frame: up to one week]

Cmax [Time Frame: up to one week]

AUC0-8 [Time Frame: up to one week]

AUC0-t [Time Frame: up to one week]

Vz/F [Time Frame: up to one week]

Secondary ID(s)

PCD-DHEC68498-17-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Covance