HealthyPhase 1NCT03534648
Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects
A Phase 1 study testing PF-06865571 administered Day 7-14, PF-06865571 administered Day 1-14 and PF-05221304 administered Day 1-14 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
Drug drug interaction study between PF-05221304 and PF-06865571 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06865571 administered Day 7-14, PF-06865571 administered Day 1-14 and PF-05221304 administered Day 1-14
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Apr 2018to 29 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects of nonchildbearing potential and/or male subjects.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Any condition possibly affecting drug absorption.
- A positive urine drug test.
- Screening supine BP 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
Drug drug interaction study between PF-05221304 and PF-06865571
Read the detailed description
A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
- Conditions
- Healthy
- Being tested
- PF-06865571 administered Day 7-14, PF-06865571 administered Day 1-14, PF-05221304 administered Day 1-14, PF-05221304 administered Day 7-14
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06865571 administered Day 7-14Drug
PF-06865571 administered Q12hr on Days 7-14
PF-06865571 administered Day 1-14Drug
PF-06865571 administered Q12hr on Day 7-14
PF-05221304 administered Day 1-14Drug
PF-05221304 administered Q12hr on Days 1-14
PF-05221304 administered Day 7-14Drug
PF-05221304 administered Q12hr Days 7-14
| Study group | Role | What they receive |
|---|---|---|
| Effect of PF-05221304 on PF-06865571 PK | Experimental | Not described Receives: Drug: PF-06865571 administered Day 7-14; Drug: PF-05221304 administered Day 1-14 |
| Effect of PF-06865571 on PF-05221304 PK | Experimental | Not described Receives: Drug: PF-06865571 administered Day 1-14; Drug: PF-05221304 administered Day 7-14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Measured: Day 7, 0-12 hours and Day 14 0-12 hours
Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Measured: Day 7, 0-12 hours and Day 14 0-12 hours
Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Measured: Day 7, 0-12 hours and Day 14 0-12 hours
Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Measured: Day 7, 0-12 hours and Day 14 0-12 hours
Secondary outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Treatment-emergent AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
Measured: Screening up to 28 days after last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start19 Apr 2018
- Primary completion16 Jul 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534648
- Sponsor's protocol ID
- C3711002
- Other IDs
- DDI, 2018-000694-70, 2018
- Status last verified
- Sep 2018
- First submitted
- 12 Apr 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03534648
- Acronym / sponsor ID
- C3711002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drug drug interaction study between PF-05221304 and PF-06865571
Detailed description
A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of PF-05221304 on PF-06865571 PK | Experimental | Drug: PF-06865571 administered Day 7-14, Drug: PF-05221304 administered Day 1-14 |
| Effect of PF-06865571 on PF-05221304 PK | Experimental | Drug: PF-06865571 administered Day 1-14, Drug: PF-05221304 administered Day 7-14 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female subjects of nonchildbearing potential and/or male subjects.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Key exclusion criteria (6 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Any condition possibly affecting drug absorption.
- A positive urine drug test.
- Screening supine BP 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06865571 administered Day 7-14PF-06865571 administered Q12hr on Days 7-14 | Drug | Effect of PF-05221304 on PF-06865571 PK |
| PF-06865571 administered Day 1-14PF-06865571 administered Q12hr on Day 7-14 | Drug | Effect of PF-06865571 on PF-05221304 PK |
| PF-05221304 administered Day 1-14PF-05221304 administered Q12hr on Days 1-14 | Drug | Effect of PF-05221304 on PF-06865571 PK |
| PF-05221304 administered Day 7-14PF-05221304 administered Q12hr Days 7-14 | Drug | Effect of PF-06865571 on PF-05221304 PK |
Primary outcome
Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Day 7, 0-12 hours and Day 14 0-12 hours
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Time frame: Day 7, 0-12 hours and Day 14 0-12 hours
Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Day 7, 0-12 hours and Day 14 0-12 hours
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
Time frame: Day 7, 0-12 hours and Day 14 0-12 hours
Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
1 secondary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Screening up to 28 days after last dose of study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06865571 administered Day 7-14, PF-06865571 administered Day 1-14 and PF-05221304 administered Day 1-14 in people with Healthy, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (time frame: Day 7, 0-12 hours and Day 14 0-12 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.