Healthy VolunteersPhase 1NCT01238679
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers
A Phase 1 study testing PF-04958242 in people with Healthy Volunteers, run by Biogen at 1 site in Singapore.
Trial summary
The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) 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 Volunteers
- 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
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Nov 2010to 3 May 2011
- 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, Randomized, Subject and Investigator-Blind, Sponsor Open, Multiple Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers
The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.
Read the detailed description
A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
- Conditions
- Healthy Volunteers
- 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 1 | Experimental | Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days. Receives: Drug: PF-04958242 |
| Cohort 2 | Experimental | Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days. Receives: Drug: PF-04958242 |
| Cohort 3 | Experimental | Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days. Receives: Drug: PF-04958242 |
| Cohort 4 | Experimental | Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days. Receives: Drug: PF-04958242 |
| Cohort 5 | Experimental | Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days. Receives: Drug: PF-04958242 |
| Cohort 6 | Experimental | Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days. Receives: Drug: PF-04958242 |
| Matching Placebo | Placebo comparator | Participants received an oral solution of matching placebo, every 12 or 24 hours for 14 days. Receives: 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 and Serious 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 up to Day 23
Maximum Plasma Drug Concentration (Cmax) for Single Dose
Measured: Day 1 and at multiple time points up to Day 17
Time to Reach Maximum Plasma Concentration (Tmax) for Single Dose
Measured: Day 1 and at multiple time points up to Day 17
Area Under the Concentration Time-curve During a Dosage Interval (AUCτ) for Single Dose
Measured: Day 1 and at multiple time points up to Day 17
Maximum Observed Plasma Concentration (Cmax) for Steady State
Measured: Day 1 and at multiple time points up to Day 17
Area Under the Plasma Drug Concentration-Time Curve During a Dosage Interval (AUCτ) for Steady State
Measured: Day 1 and at multiple time points up to Day 17
Apparent Total Clearance of the Drug from Plasma (CL/F) for Steady State
Measured: Day 1 and at multiple time points up to Day 17
Apparent Volume of Distribution During Terminal Phase (Vz/F) for Steady State
Measured: Day 1 and at multiple time points up to Day 17
Elimination Half-Life (t1/2) for Steady State
Measured: Day 1 and at multiple time points up to Day 17
Accumulation Ratio (AUC(τ,ss)/AUC(τ,sd)) for Steady State
Measured: Day 1 and at multiple time points up to Day 17
Percent of Dose Eliminated in Urine Unchanged (Ae%)
Measured: Day 14
Amount of PF-04958242 Eliminated in Urine Unchanged (Ae)
Measured: Day 14
Renal Clearance (CLr)
Measured: Day 14
Time to Reach Maximum Plasma Concentration (Tmax) for Steady State
Measured: Day 1 and at multiple time points up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study start24 Nov 2010
- Primary completion3 May 2011
- Study completion3 May 2011
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 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
- NCT01238679
- Sponsor's protocol ID
- B1701002
- Status last verified
- Dec 2019
- First submitted
- 2 Nov 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, Randomized, Subject and Investigator-Blind, Sponsor Open, Multiple Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01238679
- Acronym / sponsor ID
- B1701002
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2010 (actual)
- Primary completion
- 3 May 2011 (actual)
- Study completion
- 3 May 2011 (actual)
- First posted
- 10 Nov 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 evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.
Detailed description
A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.
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
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-04958242Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days. |
| Cohort 2 | Experimental | Drug: PF-04958242Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days. |
| Cohort 3 | Experimental | Drug: PF-04958242Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days. |
| Cohort 4 | Experimental | Drug: PF-04958242Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days. |
| Cohort 5 | Experimental | Drug: PF-04958242Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days. |
| Cohort 6 | Experimental | Drug: PF-04958242Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days. |
| Matching Placebo | Placebo comparator | Drug: PlaceboParticipants received an oral solution of matching placebo, every 12 or 24 hours for 14 days. |
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 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| PlaceboAdministered as specified in the treatment arm | Drug | Matching Placebo |
Primary outcome
Number of Participants Experiencing Adverse Events and Serious Adverse Events
Time frame: Baseline up to Day 23
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 Plasma Drug Concentration (Cmax) for Single Dose
Time frame: Day 1 and at multiple time points up to Day 17
Time to Reach Maximum Plasma Concentration (Tmax) for Single Dose
Time frame: Day 1 and at multiple time points up to Day 17
Area Under the Concentration Time-curve During a Dosage Interval (AUCτ) for Single Dose
Time frame: Day 1 and at multiple time points up to Day 17
Maximum Observed Plasma Concentration (Cmax) for Steady State
Time frame: Day 1 and at multiple time points up to Day 17
Area Under the Plasma Drug Concentration-Time Curve During a Dosage Interval (AUCτ) for Steady State
Time frame: Day 1 and at multiple time points up to Day 17
Apparent Total Clearance of the Drug from Plasma (CL/F) for Steady State
Time frame: Day 1 and at multiple time points up to Day 17
Apparent Volume of Distribution During Terminal Phase (Vz/F) for Steady State
Time frame: Day 1 and at multiple time points up to Day 17
Elimination Half-Life (t1/2) for Steady State
Time frame: Day 1 and at multiple time points up to Day 17
Accumulation Ratio (AUC(τ,ss)/AUC(τ,sd)) for Steady State
Time frame: Day 1 and at multiple time points up to Day 17
Percent of Dose Eliminated in Urine Unchanged (Ae%)
Time frame: Day 14
Amount of PF-04958242 Eliminated in Urine Unchanged (Ae)
Time frame: Day 14
Renal Clearance (CLr)
Time frame: Day 14
Time to Reach Maximum Plasma Concentration (Tmax) for Steady State
Time frame: Day 1 and at multiple time points up to Day 17
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
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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 Volunteers, 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: stopped early, 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
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 and Serious Adverse Events (time frame: Baseline up to Day 23). The study lists 14 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.