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Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir

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ClinicalTrials.gov Identifier: NCT04962230
Recruitment Status : Active, not recruiting
First Posted : July 14, 2021
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a drug-drug interaction study to assess the effects of a single dose of PF-07321332/ritonavir after multiple dose administrations of carbamazepine. Pharmacokinetic (PK) will be evaluated for PF-07321332 and ritonavir. Carbamazepine is being utilized as a cytochrome P450 3A4 (CYP3A4) inducer.

Condition or disease Intervention/treatment Phase
Healthy Participant Drug: PF-07321332/ritonavir Drug: Carbamazepine Drug: PF 07321332/ritonavir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a Phase 1, fixed sequence, 2-period study to estimate the effect of a strong CYP3A4 inducer, carbamazepine, on the PK of PF-07321332 and ritonavir in healthy participants. A total of approximately 12 healthy male and/or female participants will be enrolled into the study.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF CARBAMAZEPINE ON THE PHARMACOKINETICS OF PF-07321332 BOOSTED WITH RITONAVIR IN HEALTHY PARTICIPANTS
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Period 1
PF-07321332/ritonavir orally as a single dose
Drug: PF-07321332/ritonavir
PF-07321332/ritonavir administered orally as a single dose on Day 1, Period 1

Experimental: Period 2
Carbamazepine + PF-07321332/ritonavir orally.
Drug: Carbamazepine
In Period 2, Days 1-3, participants will receive low-dose of carbamazepine twice daily (BID), then a titrated mid-dose of carbamazepine BID on Days 4-7, and finally maintaining carbamazepine at the high-dose on Days 8-15.

Drug: PF 07321332/ritonavir
In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally.




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  2. Cmax of PF-07321332/ritonavir when administered with carbamazepine [ Time Frame: Period 2 - Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  3. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  4. AUCinf of PF-07321332/ritonavir when administered with carbamazepine [ Time Frame: Period 2 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]

Secondary Outcome Measures :
  1. Cmax of PF-07321332/ritonavir [ Time Frame: Period 2 - Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  2. AUCinf of PF-07321332/ritonavir [ Time Frame: Period 2 - Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  3. Assessment of Participants With Treatment-Emergent Adverse Events (TEAEs) of PF-07321332/Ritonavir [ Time Frame: Days 1-15 ]
  4. Assessment of Participants With Abnormalities in Physical Examination (PE) of PF-07321332/Ritonavir [ Time Frame: Days 1-15 ]
  5. Assessment of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities of PF-07321332/Ritonavir [ Time Frame: Days 1-15 ]
  6. Assessment of Participants With Clinically Significant Change From Baseline in Vital Signs of PF-07321332/Ritonavir [ Time Frame: Days 1-15 ]
  7. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings of PF-07321332/Ritonavir [ Time Frame: Days 1-15 ]
  8. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  9. Tmax of PF-07321332/ritonavir when administered with carbamazepine [ Time Frame: Period 2 - Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  10. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  11. AUClast of PF-07321332/ritonavir when administered with carbamazepine [ Time Frame: Period 2 - Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  12. Apparent Oral Clearance (CL/F) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  13. CL/F of PF-07321332/ritonavir when administered with carbamazepine [ Time Frame: Period 2 - Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  14. Apparent Volume of Distribution (Vz/F) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  15. Vz/F of PF-07321332/ritonavir when administered with carbamazepine [ Time Frame: Period 2 - Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  16. Plasma Decay Half-Life (t1/2) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  17. t1/2 of PF-07321332/ritonavir when administered with carbamazepine [ Time Frame: Period 2 - Day 14 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female participants of childbearing potential must have a negative (urine or serum) pregnancy test.
  2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  1. Positive test reverse-transcriptase polymerase chain reaction (RT-PCR) result for SARS-CoV-2 infection at the time of Screening or Day -1.
  2. Subjects shown to carry or be positive for human leukocyte antigen (HLA)-B*1502 and HLA-A*3101
  3. Participants taking monoamine oxidase inhibitors (MAOIs) should discontinue MAOI for a minimum of 14 days prior to dosing in the current study.
  4. Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, vaginal ring, and postcoital contraceptive methods) and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product. Depo Provera must be discontinued at least 6 months prior to the first dose of study treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04962230


Locations
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United States, Connecticut
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04962230    
Other Study ID Numbers: C4671014
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Drug-drug interaction
Carbamazepine
CYP3A4 inducer
Additional relevant MeSH terms:
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Ritonavir
Carbamazepine
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers