Otherwise Healthy Overweight or ObesePhase 1NCT03775278
A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
A Phase 1 study testing PHP-303 in people with Otherwise Healthy Overweight or Obese, run by pH Pharma at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Otherwise Healthy Overweight or Obese
- What is being tested?
- PHP-303
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 7 Apr 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects, ≥ 18 to ≤ 60 years of age.
- In good general health having no clinically significant diseases in medical history or evidence of clinically significant findings on physical examination, vital signs, laboratory results, and/or ECG at Screening, in the opinion of an Investigator.
- Willing to forego other forms of experimental treatment during the study.
Who cannot join
- Any clinically significant condition that, in the opinion of an Investigator, could preclude the safe participation of the subject in the study or would prevent the subject from meeting the study requirements.
- Major surgery in the 6 months preceding Screening.
- Clinically-significant abnormal laboratory parameters.
- Positive urine drug test for alcohol, cotinine, and/or drugs of abuse (cocaine, tetrahydrocannabinol, amphetamines, methamphetamines, or benzodiazepines) at Screening or on admission to the study site.
- Electrocardiographic Fridericia's corrected QT interval (QTcF) interval > 450 msec for males and > 470 msec for females, or any other clinically significant electrocardiographic abnormality.
- Blood pressure results > 150 mmHg systolic or > 95 mmHg diastolic
Show all 11Show fewer
- Female subject who is pregnant (positive pregnancy test at the Screening Visit or on admission to the study site), lactating, or planning to become pregnant during the study period or within 3 months after the final dose of study medication.
- History of drug or alcohol abuse or dependence within 1 year prior to Screening.
- History of cigarette smoking within 3 months of Screening.
- Known intolerance to lactose.
- Regular use of prescription drugs within 14 days of the first administration of study drug or non-prescription (over-the-counter) drugs within 7 days of the first administration of study drug or unwilling to abstain from prohibited medications through the end of study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of orally-administered PHP-303.
- Conditions
- Otherwise Healthy Overweight or Obese
- Being tested
- PHP-303, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHP-303Drug
Investigational drug
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | PHP-303, multiple oral dose, up to 5 ascending dose cohorts Receives: Drug: PHP-303 |
| Placebo | Placebo comparator | Placebo, multiple oral dose, up to 5 ascending dose cohorts Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events
Assess the number of patients with adverse events
Measured: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG
Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters
Measured: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - blood pressure
Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure
Measured: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - heart rate
Measured as number of heart beats per minute
Measured: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - body temperature
Measurement of oral body temperature
Measured: Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate
Measured by number of breaths per minute
Measured: Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - AUC
Area under the curve
Measured: Plasma Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - Cmax
Maximum observed concentration
Measured: Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - Tmax
Time to reach maximum measured plasma concentration
Measured: Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - t1/2
Determination of half-life
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start17 Dec 2018
- Primary completion24 Jul 2019
- Study completion7 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otherwise Healthy Overweight or ObeseStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- pH Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Nicholls, MD, PhD, Study chair, pH Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775278
- Sponsor's protocol ID
- PHP-303-N102
- Status last verified
- Apr 2020
- First submitted
- 12 Dec 2018
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
- ClinicalTrials.gov ID
- NCT03775278
- Acronym / sponsor ID
- PHP-303-N102
- Conditions
- Otherwise Healthy Overweight or Obese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- pH PharmaIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 13 Dec 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.
This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of orally-administered PHP-303.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: PHP-303PHP-303, multiple oral dose, up to 5 ascending dose cohorts |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, multiple oral dose, up to 5 ascending dose cohorts |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female subjects, ≥ 18 to ≤ 60 years of age.
- In good general health having no clinically significant diseases in medical history or evidence of clinically significant findings on physical examination, vital signs, laboratory results, and/or ECG at Screening, in the opinion of an Investigator.
- Willing to forego other forms of experimental treatment during the study.
Key exclusion criteria (11 listed)
- Any clinically significant condition that, in the opinion of an Investigator, could preclude the safe participation of the subject in the study or would prevent the subject from meeting the study requirements.
- Major surgery in the 6 months preceding Screening.
- Clinically-significant abnormal laboratory parameters.
- Positive urine drug test for alcohol, cotinine, and/or drugs of abuse (cocaine, tetrahydrocannabinol, amphetamines, methamphetamines, or benzodiazepines) at Screening or on admission to the study site.
- Electrocardiographic Fridericia's corrected QT interval (QTcF) interval > 450 msec for males and > 470 msec for females, or any other clinically significant electrocardiographic abnormality.
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 |
|---|---|---|
| PHP-303Investigational drug | Drug | Experimental |
| PlaceboMatching placebo | Other | Placebo |
Primary outcome
Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events
Time frame: Up to 12 weeks
Assess the number of patients with adverse events
Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG
Time frame: Up to 12 weeks
Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters
Safety and tolerability of multiple oral doses of PHP-303 - blood pressure
Time frame: Up to 12 weeks
Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure
Safety and tolerability of multiple oral doses of PHP-303 - heart rate
Time frame: Up to 12 weeks
Measured as number of heart beats per minute
Safety and tolerability of multiple oral doses of PHP-303 - body temperature
Time frame: Up to 12 weeks
Measurement of oral body temperature
Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate
Time frame: Up to 12 weeks
Measured by number of breaths per minute
Plasma concentration of multiple oral doses of PHP-303 - AUC
Time frame: Plasma Up to 12 weeks
Area under the curve
Plasma concentration of multiple oral doses of PHP-303 - Cmax
Time frame: Up to 12 weeks
Maximum observed concentration
Plasma concentration of multiple oral doses of PHP-303 - Tmax
Time frame: Up to 12 weeks
Time to reach maximum measured plasma concentration
Plasma concentration of multiple oral doses of PHP-303 - t1/2
Time frame: Up to 12 weeks
Determination of half-life
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 13 Apr 2020.
Related trials for Otherwise Healthy Overweight or Obese
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
Not yet recruitingPhase 1
A Study of LY4247147 in Participants With Obesity or Overweight Who Are Otherwise Healthy
Obesity, Overweight
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Active, not recruitingPhase 1
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
Healthy, Obesity
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.
Andrew Nicholls, MD, PhD study chair
pH Pharma 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 PHP-303 in people with Otherwise Healthy Overweight or Obese, run by pH Pharma 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 3 inclusion and 11 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 13 Apr 2020. 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 of multiple oral doses of PHP-303 - Incidence of Adverse Events (time frame: Up to 12 weeks). The study lists 10 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 13 Apr 2020.