A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects
1 other identifier
interventional
14
1 country
1
Brief Summary
This is a single centre, open-label, 5-period study in healthy male and non-pregnant and non-lactating healthy female subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2021
CompletedFirst Posted
Study publicly available on registry
February 24, 2021
CompletedStudy Start
First participant enrolled
March 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2021
CompletedSeptember 19, 2024
March 1, 2022
4 months
February 19, 2021
September 10, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Pharmacokinetic Assessments: Cmax
Maximum Concentration (Cmax)
72 hours
Pharmacokinetic Assessments: AUC
Area under the plasma concentration-time curve (AUC)
72 hours
Pharmacokinetic Assessments: Tmax
Time to maximum concentration (Tmax)
72 hours
Study Arms (1)
acoramidis
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy males or non-pregnant, non-lactating healthy females
- Body mass index (BMI) of 18.0 to 32.0kg/m² and a body weight\>50kg as measured at screening
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
You may not qualify if:
- Subjects who have received any IMP formulation in a clinical research study within the 90 days prior to Period 1, Day 1
- History of any drug or alcohol abuse in the past 2 years
- Subjects with pregnant or lactating partners
- Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed.
- History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4g of paracetamol per day or HRT/hormonal contraception) in the 14 days before first IMP administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Sciences
Ruddington, Nottingham, NG11 6JS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Evans, MBChB, MRCS
Quotient Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2021
First Posted
February 24, 2021
Study Start
March 28, 2021
Primary Completion
August 4, 2021
Study Completion
September 3, 2021
Last Updated
September 19, 2024
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share