Healthy VolunteerPhase 1NCT01159483
First-in-Human Study of PF-04958242 in Healthy Volunteers
A Phase 1 study testing PF-04958242 in people with Healthy Volunteer, run by Biogen at 1 site in Singapore.
Trial summary
The primary objective of this study will evaluate the safety and tolerability of single, escalating doses of PF-04958242 administered orally to healthy adult participants. This study will also evaluate the plasma pharmacokinetics (PK) of single doses of PF-04958242 after single escalating doses of PF-04958242… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- PF-04958242
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Jul 2010to 16 Oct 2010
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2);
- Total body weight >50 kilograms (kg) (110 pounds [lbs]);
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
- Positive urine drug screen;
- Pregnant or nursing females, and females of child bearing potential;
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, First-in-Human, Randomized, Subject and Investigator-Blind, Sponsor Open, Single Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pf-04958242 in Healthy Adult Volunteers
The primary objective of this study will evaluate the safety and tolerability of single, escalating doses of PF-04958242 administered orally to healthy adult participants. This study will also evaluate the plasma pharmacokinetics (PK) of single doses of PF-04958242 after single escalating doses of PF-04958242 administered orally to healthy adult participants.
Read the detailed description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
- Conditions
- Healthy Volunteer
- Being tested
- PF-04958242, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04958242Drug
Administered as specified in the treatment arm
PlaceboDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Period 1: Participants received 0.01 milligrams (mg) of PF-04958242 or matching placebo, once, orally.
Period 2: Participants received 0.03 mg of PF-04958242 or matching placebo, once, orally.
Period 3: Participants received 0.1 mg of PF-04958242 or matching placebo, once, orally. Receives: Drug: PF-04958242; Drug: Placebo |
| Cohort B | Experimental | Period 1: Participants received 0.3 mg of PF-04958242 or matching placebo, once, orally (fasted).
Period 2: Participants received 0.6 mg of PF-04958242 or matching placebo, once, orally.
Period 3: Participants received 1.0 mg of PF-04958242 or matching placebo, once, orally (fed). Receives: Drug: PF-04958242; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
An adverse event is any untoward medical occurrence in a clinical investigation subject administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Measured: Baseline to Day 4
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 and at multiple time points up to Day 4
Time to Reach Cmax (Tmax)
Measured: Day 1 and at multiple time points up to Day 4
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf)
Measured: Day 1 and at multiple time points up to Day 4
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Measured: Day 1 and at multiple time points up to Day 4
Apparent Total Plasma Clearance (CL/F)
Measured: Day 1 and at multiple time points up to Day 4
Apparent Terminal Elimination Half-life (t½)
Measured: Day 1 and at multiple time points up to Day 4
Area Under the Plasma Drug Concentration-Time Curve up to the Last Quantifiable Time-Point (AUC0-last)
Measured: Day 1 and at multiple time points up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study start15 Jul 2010
- Primary completion16 Oct 2010
- Study completion16 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by BiogenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159483
- Sponsor's protocol ID
- B1701001
- Status last verified
- Dec 2019
- First submitted
- 7 Jul 2010
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-Human, Randomized, Subject and Investigator-Blind, Sponsor Open, Single Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pf-04958242 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01159483
- Acronym / sponsor ID
- B1701001
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2010 (actual)
- Primary completion
- 16 Oct 2010 (actual)
- Study completion
- 16 Oct 2010 (actual)
- First posted
- 9 Jul 2010 (estimated)
- 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.
The primary objective of this study will evaluate the safety and tolerability of single, escalating doses of PF-04958242 administered orally to healthy adult participants. This study will also evaluate the plasma pharmacokinetics (PK) of single doses of PF-04958242 after single escalating doses of PF-04958242 administered orally to healthy adult participants.
Detailed description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: PF-04958242, Drug: PlaceboPeriod 1: Participants received 0.01 milligrams (mg) of PF-04958242 or matching placebo, once, orally. Period 2: Participants received 0.03 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 0.1 mg of PF-04958242 or matching placebo, once, orally. |
| Cohort B | Experimental | Drug: PF-04958242, Drug: PlaceboPeriod 1: Participants received 0.3 mg of PF-04958242 or matching placebo, once, orally (fasted). Period 2: Participants received 0.6 mg of PF-04958242 or matching placebo, once, orally. Period 3: Participants received 1.0 mg of PF-04958242 or matching placebo, once, orally (fed). |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2);
- Total body weight >50 kilograms (kg) (110 pounds [lbs]);
Key exclusion criteria (5 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
- Positive urine drug screen;
- Pregnant or nursing females, and females of child bearing potential;
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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-04958242Administered as specified in the treatment arm | Drug | Cohort A, Cohort B |
| PlaceboAdministered as specified in the treatment arm | Drug | Cohort A, Cohort B |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Baseline to Day 4
An adverse event is any untoward medical occurrence in a clinical investigation subject administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 and at multiple time points up to Day 4
Time to Reach Cmax (Tmax)
Time frame: Day 1 and at multiple time points up to Day 4
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf)
Time frame: Day 1 and at multiple time points up to Day 4
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Time frame: Day 1 and at multiple time points up to Day 4
Apparent Total Plasma Clearance (CL/F)
Time frame: Day 1 and at multiple time points up to Day 4
Apparent Terminal Elimination Half-life (t½)
Time frame: Day 1 and at multiple time points up to Day 4
Area Under the Plasma Drug Concentration-Time Curve up to the Last Quantifiable Time-Point (AUC0-last)
Time frame: Day 1 and at multiple time points up to Day 4
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 24 Dec 2019.
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Screening Protocol
Pain
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.
Medical Director study director
Biogen
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-04958242 in people with Healthy Volunteer, run by Biogen at 1 site in Singapore.
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 5 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 24 Dec 2019. 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 Singapore. 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?
Number of Participants Experiencing Adverse Events (time frame: Baseline to Day 4). The study lists 8 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 24 Dec 2019.