A Phase 1 interventional study of HMPL-689 and HMPL-689 placebo in Healthy Volunteers, sponsored by Hutchison Medipharma Limited. Completed at 1 site in Australia. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-17.
Sponsored by Hutchison Medipharma Limited · Phase 1, Interventional, and Health services research
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
Subjects will receive a single dose of HMPL-689 or matching placebo during Day 1. The planned dose levels are: 1, 2.5, 5, 10, 20, 25 and 30 mg (about 7 cohorts of 8 subjects). In each dose cohort, 8 subjects will be randomized to receive HMPL-689 (6 subjects) or placebo (2 subjects) under fed condition with a standard meal.
For the first dose Cohort (1 mg), a sentinel group of 2 subjects (1 HMPL-689 and 1 placebo) will be dosed 24 hours prior to the planned dosing of the remaining six subjects. The decision of dose escalation or study termination will be made jointly by the principal investigator and the sponsor based on the clinical data (safety, tolerability, available PK data and clinical laboratory values). Any dose level may be repeated, reduced or split into 2 doses if deemed appropriate by the Principal Investigator and Sponsor's medical Expert.
Hutchison Medipharma Limited is the lead sponsor of 66 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects at risk for tuberculosis (TB), which is defined as:
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
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
selective PI3Kδ inhibitor
Also known as: Huchison Medipharma
placebo of HMPL-689
Also known as: Huchison Medipharma
dose limited toxicities evaluated with NCI CTCAE v4.03
Incidence of dose limited toxicities and associated dose of HMPL-689
Time frame: within 28 days after the first dose
maximum plasma concentration calculated with Blood samples
Blood samples will be taken to measure the levels of study drug
Time frame: within 29 days after the first dose
time to reach maximum concentration calculated with Blood samples
Blood samples will be taken to measure the levels of study drug
Time frame: within 29 days after the first dose
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Hutchison Medipharma Limited