A Study of HMPL-689 in Healthy Volunteers

NCT02631642 | Completed Phase 1

• 1 other identifier: 2015-689-00AU2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of a single dose of HMPL-689 in healthy volunteers To determine the pharmacokinetic profile of single oral doses of HMPL-689 in healthy volunteers

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• dose limited toxicities evaluated with NCI CTCAE v4.03

  Incidence of dose limited toxicities and associated dose of HMPL-689

  within 28 days after the first dose

Secondary Outcomes (2)

• maximum plasma concentration calculated with Blood samples

  within 29 days after the first dose

• time to reach maximum concentration calculated with Blood samples

  within 29 days after the first dose

Study Arms (2)

HMPL-689

EXPERIMENTAL

Subjects will receive a single dose of HMPL-689 or matching placebo on Day 1. The planned dose levels in ascending order are: 1, 2.5, 5, 10, 20, 25 and 30 mg (7 dose cohorts with 8 subjects in each cohort). Within each cohort, randomization ratio of 3:1 is followed to dose 6 subjects with HMPL-689 and 2 subjects with placebo.

Drug: HMPL-689

HMPL-689 placebo

PLACEBO COMPARATOR

Subjects will receive a single dose of HMPL-689 or matching placebo on Day 1. The planned dose levels in ascending order are: 1, 2.5, 5, 10, 20, 25 and 30 mg (7 dose cohorts with 8 subjects in each cohort). Within each cohort, randomization ratio of 3:1 is followed to dose 6 subjects with HMPL-689 and 2 subjects with placebo.

Drug: HMPL-689 placebo

Interventions

HMPL-689 DRUG

selective PI3Kδ inhibitor

Also known as: Huchison Medipharma

HMPL-689

HMPL-689 placebo DRUG

placebo of HMPL-689

Also known as: Huchison Medipharma

HMPL-689 placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent must be obtained in writing for all subjects before enrollment into the study
• Healthy male subjects aged 18 to 45 years inclusive at the time of screening
• Body mass index ≥19.0 and ≤ 30.0 kg/m2
• Willing to comply with the contraceptive requirements of the study and must not donate sperm during the study or for 3 months afterwards. Subjects must agree to use a condom or to abstain from sexual intercourse throughout the trial and for 30 days afterwards

You may not qualify if:

• Family history of premature Coronary Heart Disease
• History of immunosuppression or opportunistic infections or receipt of a live virus vaccination within the 3 months prior to screening
• Clinically significant abnormalities as determined by medical history physical examination, or laboratory test, especially for liver and renal function
• Clinically significant findings in ECG, blood pressure and heart rate, as determined by the Clinical Investigator
• Subjects at risk for tuberculosis (TB), which is defined as:
• Current clinical or laboratory evidence of active TB
• History of TB
• A positive QuantiFERON® test at screening or within 6 months prior to Day 1
• Any medical condition requiring regular use of medication
• Exposure to prescription medications within 30 days prior to Day 1
• Exposure to any other medication, including over-the-counter medications, herbal remedies and vitamins 14 days prior to first dose (except for paracetamol)
• Participation in another clinical trial with any investigational drug within 30 days of Day 1
• Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ
• Current smoker of more than 10 cigarettes or equivalent/ day prior to commencing the study and unable to completely stop smoking during the study
• Symptoms of a clinically significant illness in the 3 months before the study

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3001, Australia

Location

Study Officials

• Jason Lickliter

  Nucleus Network Ltd

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: March 23, 2016
• Primary Completion: October 26, 2016
• Study Completion: February 28, 2017
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)