Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers
NCT ID: NCT05249348
Last Updated: 2024-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2021-12-20
2022-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Part 1 Sequence A
Period 1 will be fed, then washout, then Period 2 will be fasted.
PC14586
An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).
Part 1 Sequence B
Period 1 will be fasted, then washout, then Period 2 will be fed.
PC14586
An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).
Part 2 Sequence C
Period 1 will be fed, then washout, then Period 2 will be fasted. A different dose of PC14586 will be tested.
PC14586
An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).
Part 2 Sequence D
Period 1 will be fasted, then washout, then Period 2 will be fed. A different dose of PC14586 will be tested.
PC14586
An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).
Part 2 Japanese Cohort
6 Japanese participants will be administered a single dose of PC14586.
PC14586
An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).
Interventions
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PC14586
An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).
Eligibility Criteria
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Inclusion Criteria
* 18 to 55 years of age
* Able to swallow tablets.
* Japanese and born in Japan (1st generation)
* The parents and grandparents of the participant are ethnically Japanese and born in Japan
* Has undergone no significant change in lifestyle since leaving Japan
* Has lived \< 10 years outside of Japan
Exclusion Criteria
* Any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
* A p53 Y220C mutation.
* Blood pressure \>140 mm systolic or \>90 diastolic.
* Smoked or used other nicotine-containing products during the previous 3 months.
* History of alcohol and/or illicit drug abuse within the previous 5 years.
* Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV).
* Positive blood test for ethanol.
* Positive urine drug test.
* Pregnancy or breastfeeding.
* Unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical site.
* Has donated blood within 2 months prior to admission.
* Has used over-the-counter (OTC) medications (including vitamins), prescription medications or herbal remedies from 14 days prior to admission.
* Has used an investigational drug within 30 days prior to Screening.
18 Years
55 Years
ALL
Yes
Sponsors
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PMV Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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Parexel Early Phase Clinical Unit - Los Angeles
Glendale, California, United States
Countries
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Other Identifiers
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262612
Identifier Type: OTHER
Identifier Source: secondary_id
PMV-586-102
Identifier Type: -
Identifier Source: org_study_id
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