Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000101886
Ethics application status
Approved
Date submitted
14/12/2020
Date registered
1/02/2021
Date last updated
1/12/2021
Date data sharing statement initially provided
1/02/2021
Date results information initially provided
1/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Rosuvastatin Extended Release Capsules
Scientific title
An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Rosuvastatin Extended Release Capsules in Healthy Volunteers
Secondary ID [1] 302964 0
LYN-047-C-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dyslipidemia 320009 0
Condition category
Condition code
Cardiovascular 317935 317935 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves Screening from Day -28 to Day -8; Immediate release rosuvastatin dosing on Day -6, followed by a 5-day washout; and LYN-047 dosing and follow-up from Day 1 through Day 21. Therefore, patient participation in the study will range from 29 to 49 days (7 weeks).

Dosage form: Capsule containing a drug releasing formulation.
Route of administration: Oral
All participants will receive 2 doses of LYN-047(140mg), the first on Day 1 and the second on Day 8.

Immediate release rosuvastatin of 20 mg tablets will be orally administered. All participants will receive 1 dose of IR rosuvastatin on Day -6.

Only clinic staff administer the intervention. Therefore, monitoring adherence is not required.
Intervention code [1] 319254 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Active

Outcomes
Primary outcome [1] 325956 0
Safety and tolerability of LYN-047 assessed from incidence of treatment-emergent adverse events.
Safety bloods, fecal occult blood assessments, urinalysis, ECGs, physical examinations and vital signs are also used to assess outcomes.
Timepoint [1] 325956 0
Measured throughout the study (baseline till end of the study)
Safety bloods, urinalysis, physical examinations and ECGs will be performed weekly during the study. Vital signs will be measured daily from Day -1 until Day 15 and at the end of the study.
Primary outcome [2] 325957 0
To characterize the pharmacokinetics (PK) of LYN-047.
Parameters: Cmax, Cmin, Tmax, Tlast, Kel, AUC0-24, AUC0-t, AUC0-168, and AUC0-infinity.
Timepoint [2] 325957 0
Blood samples for dense PK for Dose 1 of LYN-047 will be collected starting on Day 1 and twice-daily until day 8.

Blood samples for dense PK for Dose 2 of LYN-047 will be collected on Day 8.

Day 1: 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours on Day 1 and twice-daily through the morning of Day 8 for dose 1 of LYN-047 (e.g., 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and 168 hours post-dose).
Secondary outcome [1] 389704 0
To assess the pharmacodynamics (PD) of LYN-047 regarding lipids, lipoproteins, and apolipoproteins after 2 weekly administrations.
Timepoint [1] 389704 0
Blood samples for dense PK for Dose 1 of LYN-047 will be collected starting on Day 1 and twice-daily until day 8.

Blood samples for dense PK for Dose 2 of LYN-047 will be collected on Day 8.
Day 1: 0 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on Day 8 and then 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose.

Eligibility
Key inclusion criteria
1. Men and women aged 18 to 64 years of age.
2. Individuals in good current health, in the Investigator’s opinion, as evidenced on review of medical history that includes no significant GI abnormalities, physical examination, concomitant medications, and other safety assessments.
3. Body mass index greater than or equal to 18.5 kg/m2 and lesser than 35 kg/m2.
4. Able to read and understand study procedures and provide written informed consent before the initiation of any protocol-specific procedures.
5. Willing to comply with all protocol-specified procedures and availability for the duration of the study.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Individuals with known clinically significant esophageal or GI disease, including but not limited to:
a. Known strictures such as esophageal web, pyloric stenosis, or small intestinal stricture, or individuals with high risk of stricture, i.e., Crohn's disease.
b. Diagnosis of a condition known to elevate or lower gastric pH, e.g., achlorhydria or hypochlorhydria.
c. Prior varices or small or large bowel obstructions.
d. Prior abdominal or upper GI surgery. (Prior uncomplicated laparoscopic procedures are permitted.)
2. Individuals with PILL-5 questionnaire score of 5 or greater.
3. Medical history or current diagnoses indicating the presence of any of the following conditions:
a. Presence of an uncontrolled, unstable, clinically significant medical condition that could put the subject at risk because of participation in the study, interfere with the subject’s ability to participate in the study or influence the interpretation of safety or PK evaluations.
b. History of a major cardiovascular event (myocardial infarction, cardiac surgery or revascularization, unstable angina, stroke, or transient ischemic attack) or a hospitalization for heart failure within 6 months of Screening.
c. Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of Screening.
4. Use of the following medications/treatments in the 2 weeks before enrollment, including:
a. Proton pump inhibitors (PPIs).
b. H2 blockers.
c. Chronic acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs).
d. Prokinetic agents.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/01/2021
Date of last participant enrolment
Anticipated
16/02/2021
Actual
21/02/2021
Date of last data collection
Anticipated
16/02/2021
Actual
19/03/2021
Sample size
Target
16
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18173 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 32174 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 307383 0
Commercial sector/Industry
Name [1] 307383 0
Lyndra Therapeutics, Inc. (Lyndra)
Country [1] 307383 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Lyndra Therapeutics, Inc. (Lyndra)
Address
65 Grove Street, Suite 301, Watertown, MA 02472 USA
Country
United States of America
Secondary sponsor category [1] 308039 0
Commercial sector/Industry
Name [1] 308039 0
Novotech (Australia) Pty Limited
Address [1] 308039 0
Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 308039 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307470 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 307470 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 307470 0
Australia
Date submitted for ethics approval [1] 307470 0
07/10/2020
Approval date [1] 307470 0
19/11/2020
Ethics approval number [1] 307470 0

Summary
Brief summary
This is a single center, open-label, study of rosuvastatin 140 mg ER capsules (LYN-047) to evaluate its safety, tolerability, and PK when administered as 2 weekly doses in healthy male and female volunteers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107342 0
Prof Sepehr Shakib
Address 107342 0
CMAX Clinical Research Pty Ltd.
Address: Level 5, 18a North Terrace, Adelaide, SA, 5000 Australia
Country 107342 0
Australia
Phone 107342 0
+61 8 7088 7900
Fax 107342 0
Email 107342 0
[email protected]
Contact person for public queries
Name 107343 0
Ms Merylyn Ryan
Address 107343 0
Novotech (Australia) Pty Limited
Address: Level 2, 381 MacArthur Ave Hamilton QLD 4007 Australia
Country 107343 0
Australia
Phone 107343 0
+61 3 9491 8563
Fax 107343 0
Email 107343 0
[email protected]
Contact person for scientific queries
Name 107344 0
Prof Sepehr Shakib
Address 107344 0
CMAX Clinical Research Pty Ltd.
Address: Level 5, 18a North Terrace, Adelaide, SA, 5000 Australia
Country 107344 0
Australia
Phone 107344 0
+61 8 7088 7900
Fax 107344 0
Email 107344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.