Pharmacokinetics of FidaxomicinPhase 1NCT01813448
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
A Phase 1 study testing Fidaxomicin in people with Pharmacokinetics of Fidaxomicin and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Fidaxomicin, Healthy Subjects
- What is being tested?
- Fidaxomicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Apr 2013
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continuing throughout the study period and for 90 days after final study drug administration
- Male subject must not donate sperm starting at Screening and throughout the study period and for at least 90 days after final study drug administration
- The subject is a healthy Japanese male who maintains the Japanese lifestyle, including diet and has a body mass index (BMI) of 18.0 to 28.0 kg/m2, inclusive.
- The subject is a healthy Caucasian male and has a BMI of 18.0 to 32.0 kg/m2, inclusive
Who cannot join
- The subject has any clinically significant disease history
- The subject has a history of or current C.difficile infection or history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (history of appendectomy, hernia repair, and/or cholecystectomy is permitted)
- The subject has any clinically significant abnormality
- The subject has a resting (i.e., seated for 5 minutes) pulse <40 or >90 beats per minute (bpm) at Screening or Day -2
- The subject has hypertension (defined as seated systolic blood pressure [SBP] >140 mmHg or seated diastolic blood pressure [DBP] >90 mmHg) or hypotension (defined as seated SBP <90 mmHg or seated DBP <50 mmHg) at Screening or Day -2
- The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in on Day -2
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- The subject has a history of chronic diarrhea or constipation
- The subject has a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or has a known positive history of human immunodeficiency virus (HIV)
- The subject has a known or suspected allergy or hypersensitivity to any of the components of fidaxomicin, the macrolide antibacterial class of compounds, or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Caucasian subjects.
Read the detailed description
Eligible subjects will check into the unit on Day-2 and remain confined to the clinical unit until Day 17.
Cohorts 2 and 3, which may run in parallel, will only be enrolled after review of the available safety data of Cohort 1 by the Safety Review Team.
- Conditions
- Pharmacokinetics of Fidaxomicin, Healthy Subjects
- Being tested
- Fidaxomicin, Placebo
- Keywords
- Fidaxomicin, OPT-80, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FidaxomicinDrug
Also called OPT-80, Dificlir, Dificid
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Fidaxomicin low dose in Japanese males | Experimental | Not described Receives: Drug: Fidaxomicin |
| Cohort 2: Fidaxomicin high dose in Japanese males | Experimental | Not described Receives: Drug: Fidaxomicin |
| Cohort 3: Fidaxomicin high dose in Caucasian males | Experimental | Not described Receives: Drug: Fidaxomicin |
| Matching Placebo in Caucasian males | Placebo comparator | Not described Receives: Drug: Placebo |
| Matching Placebo in Japanese males | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of fidaxomicin in plasma (single dose): Lag time (tlag)
Measured: Days 1-5 (14 times)
PK of fidaxomicin plasma (single dose): Time to attain maximum concentration (tmax)
Measured: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): Maximum Concentration (Cmax)
Measured: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): Area Under the Plasma Concentration - Time Curve (AUC) from Time Zero to Time of Last Measurable Concentration (AUClast)
Measured: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): AUC - Time Curve from Time Zero to Infinity (aucinf)
Measured: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): AUC - Time Curve from Time Zero to 12 hours (AUC 0-12h)
Measured: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): Total Body Clearance after Single Dose (CL/F)
Measured: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): Apparent Volume of Distribution During Terminal Phase (Vz/F)
Measured: Days 1-5 (14 times)
PK of fidaxomicin in plasma (last dose): Apparent Volume of Distribution During Terminal Phase (Vz/F)
Measured: Days 15-17 (11 times)
PK of fidaxomicin in plasma (single dose): Apparent Terminal elimination Half-life (t 1/2)
Single Dose
Measured: Days 1-5 (14 times)
PK of fidaxomicin in plasma (last dose): Apparent Terminal elimination Half-life (t 1/2)
Single Dose
Measured: Days 15-17 (11 times)
PK of fidaxomicin in plasma (single dose): Trough levels
Measured: Days 6, 7, 10, and 12 (pre-morning dose)
PK of fidaxomicin in plasma (last dose): tmax at Steady State (tmax, ss)
Last Dose
Measured: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): Cmax at Steady State (Cmax, ss)
Last Dose
Measured: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): AUC Over the dosing Interval (AUCtau)
Measured: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): CL/F at Steady State (CL/F ss)
Measured: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): Peak: Trough Ratio (PTR)
Measured: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): Accumulation Ratio (Racc)
Measured: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): Pre-dose Plasma Concentration Determined Directly from the Concentration-Time Profile (Ctrough)
Measured: Days 15-17 (11 times)
PK of fidaxomicin in urine (last dose): Cumulative Amount of Drug Excreted in the urine from Time Zero to Time of Last Measurable Concentration (Aelast)
Measured: Days 1-5 (6 times)
PK of fidaxomicin in urine (single dose): Percent Fraction of Administered Drug Excreted Unchanged in the urine from Time Zero to Time of Last Measurable Concentration (% Aelast )
Measured: Days 1-5 (6 times)
PK of fidaxomicin in urine (single dose): Cumulative Amount of Drug Excreted in the Urine from time Zero to Infinity after Single Dose (Aeinf)
Measured: Days 1-5 (6 times)
PK of fidaxomicin in urine (single dose): Percent Fraction of administered drug excreted unchanged in the urine from time Zero to Infinity after Single Dose (% Aeinf)
Measured: Days 1-5 (6 times)
PK of fidaxomicin in urine (single dose): Renal Clearance (CL/R
Measured: Days 1-5 (6 times)
PK of fidaxomicin in urine (last dose): Cumulative Amount of Drug Excreted in the urine over the dosing Interval at Steady State (Aetau)
Measured: Day 15 (1 time)
PK of fidaxomicin in urine (last dose): Percent Fraction of Administered Drug Excreted Unchanged in the Urine over the Dosing Interval at Steady State (% Aetau)
Measured: Day 15 (1 time)
PK of fidaxomicin in urine (last dose): Renal Clearance at Steady State (CLR,ss)
Measured: Day 15 ( 1 time)
PK of fidaxomicin in feces (single dose): Amount of Drug Excreted in the Feces (Ae)
Measured: Days 1-5 (5 times)
PK of fidaxomicin in feces (last dose): Amount of Drug Excreted in the Feces (Ae)
Measured: Days 15-17 (first bowel movement (BM) following the last dose to be collected)
PK of fidaxomicin in feces (single dose): Percent Fraction of Administered Drug Excreted Unchanged in the Feces (%Ae)
Measured: Days 1-5 (5 times)
PK of fidaxomicin in feces (last dose): Percent Fraction of Administered Drug Excreted Unchanged in the Feces (%Ae)
Measured: Days 15-17 (first BM following the last dose to be collected)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of FidaxomicinStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Sponsor
- Investigators
- Sr. Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813448
- Sponsor's protocol ID
- 2819-CL-3001
- Status last verified
- May 2014
- First submitted
- 15 Mar 2013
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT01813448
- Acronym / sponsor ID
- 2819-CL-3001
- Conditions
- Pharmacokinetics of Fidaxomicin, Healthy Subjects
- Keywords
- Fidaxomicin, OPT-80, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 Mar 2013 (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 purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Caucasian subjects.
Detailed description
Eligible subjects will check into the unit on Day-2 and remain confined to the clinical unit until Day 17.
Cohorts 2 and 3, which may run in parallel, will only be enrolled after review of the available safety data of Cohort 1 by the Safety Review Team.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Fidaxomicin low dose in Japanese males | Experimental | Drug: Fidaxomicin |
| Cohort 2: Fidaxomicin high dose in Japanese males | Experimental | Drug: Fidaxomicin |
| Cohort 3: Fidaxomicin high dose in Caucasian males | Experimental | Drug: Fidaxomicin |
| Matching Placebo in Caucasian males | Placebo comparator | Drug: Placebo |
| Matching Placebo in Japanese males | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continuing throughout the study period and for 90 days after final study drug administration
- Male subject must not donate sperm starting at Screening and throughout the study period and for at least 90 days after final study drug administration
- The subject is a healthy Japanese male who maintains the Japanese lifestyle, including diet and has a body mass index (BMI) of 18.0 to 28.0 kg/m2, inclusive.
- The subject is a healthy Caucasian male and has a BMI of 18.0 to 32.0 kg/m2, inclusive
Key exclusion criteria (9 listed)
- The subject has any clinically significant disease history
- The subject has a history of or current C.difficile infection or history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (history of appendectomy, hernia repair, and/or cholecystectomy is permitted)
- The subject has any clinically significant abnormality
- The subject has a resting (i.e., seated for 5 minutes) pulse <40 or >90 beats per minute (bpm) at Screening or Day -2
- The subject has hypertension (defined as seated systolic blood pressure [SBP] >140 mmHg or seated diastolic blood pressure [DBP] >90 mmHg) or hypotension (defined as seated SBP <90 mmHg or seated DBP <50 mmHg) at Screening or Day -2
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 |
|---|---|---|
| FidaxomicinAlso: OPT-80, Dificlir, Dificidoral | Drug | Cohort 1: Fidaxomicin low dose in Japanese males, Cohort 2: Fidaxomicin high dose in Japanese males, Cohort 3: Fidaxomicin high dose in Caucasian males |
| Placebooral | Drug | Matching Placebo in Caucasian males, Matching Placebo in Japanese males |
Primary outcome
Pharmacokinetics (PK) of fidaxomicin in plasma (single dose): Lag time (tlag)
Time frame: Days 1-5 (14 times)
PK of fidaxomicin plasma (single dose): Time to attain maximum concentration (tmax)
Time frame: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): Maximum Concentration (Cmax)
Time frame: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): Area Under the Plasma Concentration - Time Curve (AUC) from Time Zero to Time of Last Measurable Concentration (AUClast)
Time frame: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): AUC - Time Curve from Time Zero to Infinity (aucinf)
Time frame: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): AUC - Time Curve from Time Zero to 12 hours (AUC 0-12h)
Time frame: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): Total Body Clearance after Single Dose (CL/F)
Time frame: Days 1-5 (14 times)
PK of fidaxomicin in plasma (single dose): Apparent Volume of Distribution During Terminal Phase (Vz/F)
Time frame: Days 1-5 (14 times)
PK of fidaxomicin in plasma (last dose): Apparent Volume of Distribution During Terminal Phase (Vz/F)
Time frame: Days 15-17 (11 times)
PK of fidaxomicin in plasma (single dose): Apparent Terminal elimination Half-life (t 1/2)
Time frame: Days 1-5 (14 times)
Single Dose
PK of fidaxomicin in plasma (last dose): Apparent Terminal elimination Half-life (t 1/2)
Time frame: Days 15-17 (11 times)
Single Dose
PK of fidaxomicin in plasma (single dose): Trough levels
Time frame: Days 6, 7, 10, and 12 (pre-morning dose)
PK of fidaxomicin in plasma (last dose): tmax at Steady State (tmax, ss)
Time frame: Days 15-17 (11 times)
Last Dose
PK of fidaxomicin in plasma (last dose): Cmax at Steady State (Cmax, ss)
Time frame: Days 15-17 (11 times)
Last Dose
PK of fidaxomicin in plasma (last dose): AUC Over the dosing Interval (AUCtau)
Time frame: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): CL/F at Steady State (CL/F ss)
Time frame: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): Peak: Trough Ratio (PTR)
Time frame: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): Accumulation Ratio (Racc)
Time frame: Days 15-17 (11 times)
PK of fidaxomicin in plasma (last dose): Pre-dose Plasma Concentration Determined Directly from the Concentration-Time Profile (Ctrough)
Time frame: Days 15-17 (11 times)
PK of fidaxomicin in urine (last dose): Cumulative Amount of Drug Excreted in the urine from Time Zero to Time of Last Measurable Concentration (Aelast)
Time frame: Days 1-5 (6 times)
PK of fidaxomicin in urine (single dose): Percent Fraction of Administered Drug Excreted Unchanged in the urine from Time Zero to Time of Last Measurable Concentration (% Aelast )
Time frame: Days 1-5 (6 times)
PK of fidaxomicin in urine (single dose): Cumulative Amount of Drug Excreted in the Urine from time Zero to Infinity after Single Dose (Aeinf)
Time frame: Days 1-5 (6 times)
PK of fidaxomicin in urine (single dose): Percent Fraction of administered drug excreted unchanged in the urine from time Zero to Infinity after Single Dose (% Aeinf)
Time frame: Days 1-5 (6 times)
PK of fidaxomicin in urine (single dose): Renal Clearance (CL/R
Time frame: Days 1-5 (6 times)
PK of fidaxomicin in urine (last dose): Cumulative Amount of Drug Excreted in the urine over the dosing Interval at Steady State (Aetau)
Time frame: Day 15 (1 time)
PK of fidaxomicin in urine (last dose): Percent Fraction of Administered Drug Excreted Unchanged in the Urine over the Dosing Interval at Steady State (% Aetau)
Time frame: Day 15 (1 time)
PK of fidaxomicin in urine (last dose): Renal Clearance at Steady State (CLR,ss)
Time frame: Day 15 ( 1 time)
PK of fidaxomicin in feces (single dose): Amount of Drug Excreted in the Feces (Ae)
Time frame: Days 1-5 (5 times)
PK of fidaxomicin in feces (last dose): Amount of Drug Excreted in the Feces (Ae)
Time frame: Days 15-17 (first bowel movement (BM) following the last dose to be collected)
PK of fidaxomicin in feces (single dose): Percent Fraction of Administered Drug Excreted Unchanged in the Feces (%Ae)
Time frame: Days 1-5 (5 times)
PK of fidaxomicin in feces (last dose): Percent Fraction of Administered Drug Excreted Unchanged in the Feces (%Ae)
Time frame: Days 15-17 (first BM following the last dose to be collected)
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 21 May 2014.
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.
Sr. Medical Director study director
Astellas Pharma Global Development, Inc.
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 Fidaxomicin in people with Pharmacokinetics of Fidaxomicin and Healthy Subjects, run by Astellas Pharma Global Development, Inc. at 1 site in United States.
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 4 inclusion and 9 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 21 May 2014. 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 United States. 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 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?
Pharmacokinetics (PK) of fidaxomicin in plasma (single dose): Lag time (tlag) (time frame: Days 1-5 (14 times)). The study lists 31 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 21 May 2014.