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HealthyPhase 1NCT01290276

Open-label, Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation

A Phase 1 study testing Ond-PR1, Ond-PR1 + MPh-IR and Ond-PR2 in people with Healthy, run by Tong Lee at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goals of this open-label Phase Ia study are to evaluate the Pharmacokinetics (PK) profiles of new novel single-dose Ondansetron Pulsatile Release (Ond-PR) formulations in normal healthy volunteers. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ond-PR1, Ond-PR1 + MPh-IR and Ond-PR2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Dec 2010to Aug 2012
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

  • Subjects must give written informed consent to participate in the study prior to screening. Consent will be documented by the subject's dated signature that will be counter-signed and dated by a witness.
  • Healthy non-smoking, by history, adult male and/or female volunteers between the ages of 18 and 45 years old and with a Body Mass Index (BMI) of ≥18-≤32 kg/m2.
  • Subjects must be in good health as determined by screening medical history, physical examination, vital signs, electrocardiogram, blood chemistry, hematology, and urinalysis (U/A) performed at screening.
  • Normal Hematology Clinical Laboratory, Results, including: Normal White Blood Cell (WBC) and differential, Hematocrit, Hemoglobin, Platelet Counts
  • Normal Electrocardiogram (ECG) and a measure between Q wave and T wave in the heart's electrical cycle at baseline (QTcB) ≤ 430 msec (males) or ≤ 430 msec (females)

Who cannot join

  • Male and/or female subjects who consume more than 28 units of alcohol per week (one unit of alcohol equals ½ pint of beer, 4 ounces of wine, or 1 ounce of spirits) or those subjects who have a significant history of alcoholism or drug/chemical abuse within the last 2 years. Subjects must agree to abstain from alcohol, cola, tea, coffee, chocolate and other caffeinated drink and food from 2 days before Period 1, Day 1 and throughout confinement.
  • Subjects who have used tobacco products or nicotine-containing products (including smoking cessation aids, such as gums or patches) within 3 months prior to Day -1.
  • Subjects with positive results on tests for drugs of abuse, or alcohol at screening and check-in.
  • Concomitant Medications: Any drugs, vitamins, over the counter (OTC) medicines and nutraceuticals if used within the previous 7 days of check-in as deemed clinically significant by the Principal Investigator (PI).
  • Subjects who have used any drugs or substances known to be strong inhibitors or strong inducers of CYP 3A4/5 enzymes (also known as cytochrome P-450 enzymes) or P-Glycoprotein (Pgp) within 30 days prior to Period 1, Day -1. Subjects must agree to abstain from grapefruit/grapefruit juice and seville oranges for 2 days before period Ia, Day -1 and throughout the study.
  • Use of other investigational drugs at the time of enrollment (consenting), or 5 half-lives of enrollment whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
Show all 19Show fewer
  • History of unstable psychiatric illness requiring medications or hospitalization within the previous 12 months.
  • History of concurrent illness that required hospitalization within 14 days prior to Day 1 of the study.
  • Any condition that in the clinical judgment of the Investigator would make the subject unsuitable for participation.
  • Allergies or allergic reactions to any of the products used in this study.
  • Subjects who have had a clinically significant illness within 4 weeks prior to Day -1.
  • Subjects with QTcB interval duration >430 msec (males) or >450 (females) obtained from the ECG recorder's measurements on the screening ECG taken after at least 5 minutes of quiet rest in supine position.
  • History or current evidence of clinically significant hepatic, renal, cardiovascular (i.e., deep venous thrombosis, pulmonary embolism), psychological, pulmonary, metabolic, endocrine, neurologic (i.e., transient ischemic attack or stroke within the past 6 months) infectious, gastrointestinal (i.e., any condition which may affect drug absorption) hematologic, oncologic disease, retinopathy, or other medical disorders, as determined by screening history, physical examination, laboratory test results, or 12-lead ECG.
  • History of unexplained syncope.
  • Subjects with creatinine clearance < 80 mL/min (based on Cockcroft-Gault equation).
  • Subjects who, in the opinion of the Investigator, should not participate in the study.
  • Any employee of the Duke Clinical Research Unit (DCRU).
  • Subjects who have blood relatives of another study participant.
  • Subjects must be compliant and meet all inclusion and exclusion criteria unless, following discussions between the Principal Investigator or his designate, it is determined that a minor exception is not indicative of clinically significant safety risk and unlikely to confound the results of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Phase Ia/Ib Study of Normal Healthy Volunteer Clinical Trial of a Novel Ondansetron Formulation

The goals of this open-label Phase Ia study are to evaluate the Pharmacokinetics (PK) profiles of new novel single-dose Ondansetron Pulsatile Release (Ond-PR) formulations in normal healthy volunteers. After this initial phase, the investigators will follow with the Phase Ib study to determine Pharmacokinetic/Pharmacodynamic (PK/PD), safety, and tolerability interactions following simultaneous administration of these ondansetron formulations with a 10 mg Methylphenidate Immediate Release (MPh-IR) tablet in normal healthy volunteers.

Read the detailed description

We will compare 2 different pulsatile-release formulations of ondansetron, PR1 and PR2. Ond-PR1 is a pH-sensitive formulation while Ond-PR2 is osmotic-sensitive.

Conditions
Healthy
Being tested
Ond-PR1, Ond-PR1 + MPh-IR, Ond-PR2, Ond-PR2 +_ MPh-IR
Keywords
Ondansetron, Methylphenidate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ond-PR1Drug

    Also called Zofran (ondansetron hydrochloride)

    Single oral dose of 8 mg of ondansetron pulsatile-release formulation 1 (Ond-PR1)

  • Ond-PR1 + MPh-IRDrug

    Also called Zofran (ondansetron hydrochloride), Ritalin (methylphenidate hydrochloride)

    Single oral dose of 8 mg of ondansetron pulsatile-release formulation 1 (Ond-PR1) plus 10 mg methylphenidate immediate release (Mph-IR)

  • Ond-PR2Drug

    Also called Zofran (ondansetron hydrochloride)

    Single oral dose of 8 mg ondansetron pulsatile-release formulation 2 (Ond-PR2)

  • Ond-PR2 +_ MPh-IRDrug

    Also called Zofran (ondansetron hydrochloride), Ritalin (methylphenidate hydrochloride)

    Single oral dose of 8 mg of ondansetron pulsatile-release formulation 2 (Ond-PR2) plus 10 mg methylphenidate immediate release (Mph-IR)

Study groups in NCT01290276
Study groupRoleWhat they receive
Ond-PR1 followed by (Ond-PR1 + MPh-IR)ExperimentalOral dose of 8 mg of ondansetron pulsatile-release formulation 1 followed by Oral dose of 8 mg of ondansetron pulsatile-release formulation 1 (Ond-PR1) plus 10 mg methylphenidate immediate release (Mph-IR)
Receives: Drug: Ond-PR1; Drug: Ond-PR1 + MPh-IR; Drug: Ond-PR2; Drug: Ond-PR2 +_ MPh-IR
Ond-PR2 followed by (Ond-PR2 + MPh-IR)ExperimentalOral dose of 8 mg of ondansetron pulsatile-release formulation 2 followed by Oral dose of 8 mg of ondansetron pulsatile-release formulation 2 (Ond-PR2) plus 10 mg methylphenidate immediate release (Mph-IR)
Receives: Drug: Ond-PR1; Drug: Ond-PR1 + MPh-IR; Drug: Ond-PR2; Drug: Ond-PR2 +_ MPh-IR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The release profile of Ondansetron Pulsatile Release (Ond-PR) in the human gastrointestinal (GI) tract matches the one predicted from test tube dissolution experiments.

    Serum levels of ondansetron after oral administration of Ond-PR in healthy human volunteers. Standard PK parameters will be calculated based on the serum levels to verify that the drug levels reach the peak blood concentration 5 - 6 hours after oral administration.

    Time Frame: Blood samples will be taken immediately before oral Ond-PR administration, followed by sampling at 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6 and 10 hours after drug administration.

    Measured: The time to reach peak blood concentration (tmax) for oral Ondansetron Standard (Ond-St) is ~2 hours (h). Therefore, tmax for Ond-PR with in vitro dissolution time of 3 - 4 h is expected to be 5 - 6 h (i.e., 3 - 4 h delay + normal absorption time).

Secondary outcomes (1)

  1. To determine drug-drug interactions of Ond-PR with a simultaneously-administered MPh-IR.

    For our secondary objective we plan to determine drug-drug interactions between Ond-PR and MPh-IR when they are simultaneously administered orally. Specific parameters to be assessed include changes in the PK, properties (see above for the specific parameter list), safety/tolerability profiles of Ond-PR.

    Measured: 5 - 6 h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01290276
Sponsor's protocol ID
Pro00024378
Other IDs
110034 (Pro00024378), 110195 (Pro00026674), Pro00026674
Status last verified
Jul 2014
First submitted
9 Jan 2011
Last updated
1 Aug 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ond-PR1, Ond-PR1 + MPh-IR and Ond-PR2 in people with Healthy, run by Tong Lee 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 5 inclusion and 19 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 1 Aug 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. 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?

The release profile of Ondansetron Pulsatile Release (Ond-PR) in the human gastrointestinal (GI) tract matches the one predicted from test tube dissolution experiments. (time frame: The time to reach peak blood concentration (tmax) for oral Ondansetron Standard (Ond-St) is ~2 hours (h). Therefore, tmax for Ond-PR with in vitro dissolution time of 3 - 4 h is expected to be 5 - 6 h (i.e., 3 - 4 h delay + normal absorption time).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01290276.

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 1 Aug 2014.

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