Drug ToxicityPhase 1NCT01135680
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
A Phase 1 study testing HPN-100 and Moxifloxacin in people with Drug Toxicity, run by Amgen at 1 site in United States.
Trial summary
Arm 1: Primary Objective: To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100. Arm 2: Primary Objective: To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid [PBA], phenylacetic acid [PAA], and phenylacetylglutamine [PAGN]) on 12-lead… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Toxicity
- What is being tested?
- HPN-100 and Moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be in good health
- Negative hepatitis panel and negative HIV antibody screens
- Females must be non-pregnant, non-lactating, and either postmenopausal or agree to to use adequate contraceptive methods throughout the study
- Males must either be sterile or willing to use adequate contraceptive methods throughout the study
- Willing and able to comply with all trial requirements
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
Who cannot join
- History or clinical manifestations of significant allergic, metabolic, hepatic, renal, endocrine, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders
- History of hypersensitivity or allergies to any drug compound
- History of stomach or intestinal surgery or resection
- History or presence of an abnormal ECG
- History of alcoholism or drug addiction within 1 year
- Use of any tobacco-containing or nicotine-containing products within 3 months
Show all 14Show fewer
- Participated in any other clinical trial of an investigational drug (or a medical device) within 30 days
- Use of any prescription medications/products other than contraceptives within 14 days
- Use of any over-the-counter, non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days
- Test positive for drug(s) of abuse, ethanol, or cotinine
- Have donated blood or blood components within 30 days
- Have received blood products within 2 months
- Have a history of unexplained syncope
- Have a family history of unexplained sudden death
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Pharmacology, Inc.
Madison, Wisconsin, 53704
About this study
Official title: Double-Blind Randomized Placebo-Control Trial to Evaluate Electrocardiogram Effects of HPN-100 as Defined by Clinical and Supratherapeutic Dose in Healthy Men and Women
Arm 1:
Primary Objective:
- To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100.
Arm 2:
Primary Objective:
- To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid [PBA], phenylacetic acid [PAA], and phenylacetylglutamine [PAGN]) on 12-lead electrocardiogram (ECG) parameters in healthy male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate (HR) based on an individual correction method (QTcI).
Read the detailed description
Assess the effects of steady-state levels of HPN-100 metabolites (4-phenylbutryic acid (PBA), phenylacetic acid (PAA), and phenylacetylglutamine (PAGN) on 12-lead electrocardiogram (ECG) parameters in health male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate(HR) based on an individual correction method (QTcl).
Study acquired from Horizon in 2024.
- Conditions
- Drug Toxicity
- Being tested
- HPN-100, HPN-100 or Placebo, Placebo, Moxifloxacin
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPN-100Drug
single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days
HPN-100 or PlaceboDrug
single oral dose of 12 mL HPN-100 given via syringes 3 times daily for 3 days
PlaceboDrug
single oral (by mouth) dose of 9 mL placebo given via syringes 3 times daily for 3 days
MoxifloxacinDrug
single oral 400-mg dose on study Day 3
HPN-100Drug
single oral dose of 6 mL HPN-100 and 3 mL placebo given via syringes 3 times daily for 3 days
HPN-100Drug
single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Cohort A: 9 mL HPN-100 or placebo
Cohort B: 12 mL HPN-100 placebo Receives: Drug: HPN-100; Drug: HPN-100 or Placebo |
| Arm 2 | Placebo comparator | This study requires 4 periods. In each of the periods you will receive one of the dose groups listed below. At the completion of the study you will have participated in all 4 dose groups. The order in which you participate in each dose group will be randomly assigned.
Dose Group A: 9 mL placebo via oral syringe 3 times daily for 3 days
Dose Group B: single oral dose of 400 mg moxifloxacin on study Day 3
Dose Group C: 6 mL HPN-100 and 3 mL placebo via oral syringe 3 times daily for 3 days
Dose Group D: 9 mL HPN-100 via oral syringe 3 times daily for 3 days Receives: Drug: Placebo; Drug: Moxifloxacin; Drug: HPN-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by the rate and severity of adverse events in each treatment group.
Measured: 3-day treatment period
Changes from baseline QTcI as a measure of effects of study-state HPN-100 metabolites: PBA, PAA, and PAGN
Measured: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
Secondary outcomes (4)
Correlate time-matched ECG waveform changes to steady-state levels of HPN-100 by using QTcB and QTcF formulas to assess ECG morphologic changes.
Measured: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
Correlate time-matched QTcI change from baseline and serum levels of PBA, PAA, and PAGN drawn on Day 1, Day 2, Day 3, and Day 4
Measured: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
Gender differences in metabolism of HPN-100 as measured by time-matched serum levels of HTN-100, PBA, PAA, and PAGN via samples drawn on Day 1, Day 2, Day 3, and Day 4.
Measured: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
Number and severity of adverse events in each treatment group.
Measured: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ToxicityStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135680
- Sponsor's protocol ID
- HPN-100-010
- Status last verified
- Jun 2024
- First submitted
- 31 May 2010
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Placebo-Control Trial to Evaluate Electrocardiogram Effects of HPN-100 as Defined by Clinical and Supratherapeutic Dose in Healthy Men and Women
- ClinicalTrials.gov ID
- NCT01135680
- Acronym / sponsor ID
- HPN-100-010
- Conditions
- Drug Toxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Jun 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.
Arm 1:
Primary Objective:
- To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100.
Arm 2:
Primary Objective:
- To assess the effects of steady-state levels of HPN-100 metabolites (4 phenylbutyric acid [PBA], phenylacetic acid [PAA], and phenylacetylglutamine [PAGN]) on 12-lead electrocardiogram (ECG) parameters in healthy male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate (HR) based on an individual correction method (QTcI).
Detailed description
Assess the effects of steady-state levels of HPN-100 metabolites (4-phenylbutryic acid (PBA), phenylacetic acid (PAA), and phenylacetylglutamine (PAGN) on 12-lead electrocardiogram (ECG) parameters in health male and female subjects with the primary endpoint being the time-matched change from baseline in the QT interval corrected for heart rate(HR) based on an individual correction method (QTcl).
Study acquired from Horizon in 2024.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: HPN-100, Drug: HPN-100 or PlaceboCohort A: 9 mL HPN-100 or placebo Cohort B: 12 mL HPN-100 placebo |
| Arm 2 | Placebo comparator | Drug: Placebo, Drug: Moxifloxacin, Drug: HPN-100This study requires 4 periods. In each of the periods you will receive one of the dose groups listed below. At the completion of the study you will have participated in all 4 dose groups. The order in which you participate in each dose group will be randomly assigned. Dose Group A: 9 mL placebo via oral syringe 3 times daily for 3 days Dose Group B: single oral dose of 400 mg moxifloxacin on study Day 3 Dose Group C: 6 mL HPN-100 and 3 mL placebo via oral syringe 3 times daily for 3 days Dose Group D: 9 mL HPN-100 via oral syringe 3 times daily for 3 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must be in good health
- Negative hepatitis panel and negative HIV antibody screens
- Females must be non-pregnant, non-lactating, and either postmenopausal or agree to to use adequate contraceptive methods throughout the study
- Males must either be sterile or willing to use adequate contraceptive methods throughout the study
- Willing and able to comply with all trial requirements
Key exclusion criteria (14 listed)
- History or clinical manifestations of significant allergic, metabolic, hepatic, renal, endocrine, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders
- History of hypersensitivity or allergies to any drug compound
- History of stomach or intestinal surgery or resection
- History or presence of an abnormal ECG
- History of alcoholism or drug addiction within 1 year
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 |
|---|---|---|
| HPN-100single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days | Drug | Arm 1 |
| HPN-100 or Placebosingle oral dose of 12 mL HPN-100 given via syringes 3 times daily for 3 days | Drug | Arm 1 |
| Placebosingle oral (by mouth) dose of 9 mL placebo given via syringes 3 times daily for 3 days | Drug | Arm 2 |
| Moxifloxacinsingle oral 400-mg dose on study Day 3 | Drug | Arm 2 |
| HPN-100single oral dose of 6 mL HPN-100 and 3 mL placebo given via syringes 3 times daily for 3 days | Drug | Arm 2 |
| HPN-100single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days | Drug | Arm 2 |
Primary outcome
Safety and tolerability as measured by the rate and severity of adverse events in each treatment group.
Time frame: 3-day treatment period
Changes from baseline QTcI as a measure of effects of study-state HPN-100 metabolites: PBA, PAA, and PAGN
Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
4 secondary outcomes
Correlate time-matched ECG waveform changes to steady-state levels of HPN-100 by using QTcB and QTcF formulas to assess ECG morphologic changes.
Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
Correlate time-matched QTcI change from baseline and serum levels of PBA, PAA, and PAGN drawn on Day 1, Day 2, Day 3, and Day 4
Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
Gender differences in metabolism of HPN-100 as measured by time-matched serum levels of HTN-100, PBA, PAA, and PAGN via samples drawn on Day 1, Day 2, Day 3, and Day 4.
Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
Number and severity of adverse events in each treatment group.
Time frame: 4 treatment regimens for 3 days with a 4 day minimum washout period between treatments
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 20 Jun 2024.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
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 HPN-100 and Moxifloxacin in people with Drug Toxicity, run by Amgen 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 6 inclusion and 14 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 20 Jun 2024. 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?
Safety and tolerability as measured by the rate and severity of adverse events in each treatment group. (time frame: 3-day treatment period). The study lists 2 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 20 Jun 2024.