A Study to Learn About the Study Medicine Called Nirmatrelvir/Ritonavir in People Who are Healthy Volunteers Co-administered the Medicine Rosuvastatin

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

2 Jun 2023 → 11 Aug 2023

Decision date (initial)

2023-05-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic

To assess the effect of multiple doses of nirmatrelvir/ritonavir on the plasma pharmacokinetics of a single, oral dose of rosuvastatin in healthy participants.

Secondary objectives 2

1. To further characterize the plasma pharmacokinetics of a single, oral dose of rosuvastatin administered with nirmatrelvir/ritonavir.
2. To evaluate the safety and tolerability of a single oral dose of rosuvastatin when coadministered with nirmatrelvir/ritonavir.

Conditions and MedDRA coding

coronavirus disease 2019 (COVID-19)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male and female participants aged 18 years (or the minimum age to consent in accordance with local regulations) or older at Screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead electrocardiogram (ECG).
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Female participants must have a negative pregnancy test.
4. Body mass index (BMI) of 16-32 kg/m2 and a total body weight >50 kg (110 lb).
5. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Exclusion criteria 5

1. Positive test result for SARS-CoV-2 infection on Day -1 or who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement.
2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). - Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). - History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
3. Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy- or brady-arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association Functioncal Classification 1 (NYHA 1), underlying structural heart disease, Wolff Parkinson-White syndrome).
4. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
5. Participants, who according to the product label for rosuvastatin, would be at increased risk if dosed with rosuvastatin.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. AUCinf and Cmax of rosuvastatin

Secondary endpoints 2

1. AUClast, Tmax, t½, CL/F, and Vz/F of rosuvastatin
2. Vital signs, laboratory tests and adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

235 East 42nd Street

City

New York

Postcode

10017-5703

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Trials.gov Call Centre

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Trials.gov Call Centre

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications