PainPhase 1NCT03765801

A Clinical Study in Healthy Women Which Aims to Explore the Intestinal Uptake of Two Different Tablets of GRTA9906 Into the Body and the Effect of Food on it

A Phase 1 study testing GRTA9906 60 mg PR tablet and GRTA9906 60 mg IR capsule in people with Pain and Neuropathic Pain, run by Grünenthal GmbH at 1 site in Germany.

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

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pain, Neuropathic Pain, Chronic Pain
What is being tested?: GRTA9906 60 mg PR tablet and GRTA9906 60 mg IR capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteGermany
Study dates: 22 Oct 2003to 11 Dec 2003
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 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female Caucasian volunteers aged 18 - 55 years.
Body mass index between 18 and 29 kilograms per square meter inclusive.
Good physical and mental health status (no current acute illness) determined on the basis of the medical history and a general clinical examination.
Normal supine blood pressure (systolic blood pressure greater than or equal to 90 Millimeter mercury (mmHg) and less than or equal to 145 mmHg, diastolic blood pressure greater than or equal to 45mmHg and less than or equal to 90 mmHg) and pulse (greater than or equal to 45 and less than or equal to 90 beats per minute).
Electrocardiogram (12 lead) considered as normal by the Investigator.
Results of laboratory tests within the normal ranges for the testing laboratory. The Investigator may include a participant having values outside the accepted range if, in his/her opinion, these values are of no clinical relevance. The decision will be justified.

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Participants giving written consent to participate in this trial.
Negative pregnancy test (females of childbearing potential only).
Adequate contraception (females of childbearing potential only; adequate contraception is defined as any form of hormonal contraception or intra-uterine device that needs to be in place for a period of at least 2 months prior to screening. Additional barrier contraception must be used for the duration of the study, defined as from the time of screening to the post-study medical examination, and for at least one full month thereafter. A single barrier method alone or abstinence alone is not acceptable. Women of non-childbearing potential may be included if surgically sterile or post-menopausal for at least 2 years).
Must be able to tolerate high-fat and high-calorie study-meal.

Who cannot join

Diseases and functional disorders of the gastrointestinal tract, hepatobiliary system, renal system or cardiovascular system including marked repolarisation abnormality (e.g. suspicious or definite congenital long QT syndrome) or co-medication that is known to influence cardiac repolarisation substantially.
Malignancy.
History of orthostatic hypotension.
Positive human immunodeficiency virus HIV1/2-antibodies, hepatitis B surface-antigen (HBs), hepatitis B core-antibodies (HBc), Hepatitis C virus (HCV) antibody tests at the prestudy medical examination.
Drug allergy.
Bronchial asthma.

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Participation in another clinical study in the last three months before starting this study (exception: characterisation of metaboliser status).
Blood donation (more than 100 milliliter) in the last three months before the start of the study.
Evidence of alcohol, medication or drug abuse.
Positive drug abuse screening test.
Extremely unbalanced diet (in the opinion of the investigator).
Excessive consumption of food or beverages containing caffeine or other xanthines (more than five cups of coffee or equivalent per day).
Smoking of more than 20 cigarettes per day.
Known or suspected of not being able to comply with the study protocol.
Neurotic personality, psychiatric illness, or suicide risk.
History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis, unclear loss of consciousness).
Pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Dept. of Human Pharmacology
Aachen, 52078

Other trials in Germany

About this study

Official title: Phase I, Single-center Study to Explore the Relative Bioavailability and the Effect of Food on the Bioavailability of Prolonged Release Tablets Compared to Immediate Release Capsules Each Containing 60 mg of GRTA9906 in 20 Healthy Female Volunteers

The aim of this clinical study in healthy women is to explore the intestinal uptake (bioavailability) of two different tablets of GRTA9906 (formulations) into the body and the effect of food on it. The intake of food may considerably influence the bioavailability, either by interaction with the compound itself or, if a prolonged release (PR) formulation is used, with the components of the tablet-matrix. For these reasons, the relative bioavailability and the effect of food on the bioavailability of GRTA9906 given as PR tablets compared to immediate release (IR) capsules will be assessed in this study.

During the 4 periods of the study, each participant will receive two 60 mg GRTA9906 PR matrix tablets and two 60 mg GRTA9906 IR capsules under fed conditions (after consumption of a high-fat and high-calorie test meal) and fasting conditions (10 hours before dosing until 4.5 hours after dosing). In each period, the participant will receive the investigational product once.

Conditions: Pain, Neuropathic Pain, Chronic Pain, Visceral Pain
Being tested: GRTA9906 60 mg PR tablet, GRTA9906 60 mg IR capsule
Medical subject headings: Pain, Neuralgia, Chronic Pain, Visceral Pain

What participants receive

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

GRTA9906 60 mg PR tabletDrug
GRTA9906 60 mg PR tablet
GRTA9906 60 mg IR capsuleDrug
GRTA9906 60 mg IR capsule

Study groups in NCT03765801
Study group	Role	What they receive
GRTA9906 60 mg PR tablet (fed)	Experimental	Participants will receive two 60 mg GRTA9906 PR matrix tablets under fed conditions after consumption of a high-fat and high-calorie test meal. Receives: Drug: GRTA9906 60 mg PR tablet
GRTA9906 60 mg PR tablet (fasting)	Experimental	Participants will receive two 60 mg GRTA9906 PR matrix tablets under fasting conditions (10 hours before dosing until 4.5 hours after dosing). Receives: Drug: GRTA9906 60 mg PR tablet
GRTA9906 60 mg IR capsule (fed)	Experimental	Participants will receive two 60 mg GRTA9906 IR capsules under fed conditions after consumption of a high-fat and high-calorie test meal. Receives: Drug: GRTA9906 60 mg IR capsule
GRTA9906 60 mg IR capsule (fasting)	Experimental	Participants will receive two 60 mg GRTA9906 IR capsules under fasting conditions (10 hours before dosing until 4.5 hours after dosing). Receives: Drug: GRTA9906 60 mg IR capsule

What is being measured

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

Pharmacokinetic parameter - AUC0-tz
Area under the concentration vs. time curve from dosing time to the last measured concentration above the lower limit of quantitation. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Pharmacokinetic parameter - AUC0-inf
Total area under the concentration vs. time curve (from dosing time to infinity). The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Pharmacokinetic parameter - tmax
Time to reach maximum serum concentration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Pharmacokinetic parameter - Cmax
Maximum serum concentration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Pharmacokinetic parameter - lag-time (tlag)
Period of time from the administration of the investigational product to the first measured concentration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Pharmacokinetic parameter - t(½,z)
Apparent terminal half-life. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Pharmacokinetic parameter - MRT
Mean residence time. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Pharmacokinetic parameter - HVD
Half-value duration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Pharmacokinetic parameter - CL/f
Total clearance. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Pharmacokinetic parameter - Vz/f
Apparent volume of distribution during the terminal phase. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Measured: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose

Secondary outcomes (4)

Pupillometry parameter - Initial diameter (mm)
Diameter in millimeter (mm) before presentation of the light stimulus. Pupillometry will be carried out using a Compact Integrated Pupillograph (CIP) in a darkened room.
Measured: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Pupillometry parameter - Latency time (sec)
Time in seconds (sec) between begin of the light stimulus and onset of pupil reaction.
Measured: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Pupillometry parameter - Amplitude (mm)
Difference in millimeter (mm) between initial value and minimum diameter.
Measured: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Pupillometry parameter - Constriction time (sec)
Time in seconds (sec) between onset of reaction and minimum diameter.
Measured: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose

Timeline

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

22 Oct 200311 Dec 2003

First posted5 Dec 2018
Study start22 Oct 2003
Primary completion11 Dec 2003
Study completion11 Dec 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PainStudies 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: Crossover
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03765801
Sponsor's protocol ID: HP9906/06
Status last verified: Dec 2018
First submitted: 4 Dec 2018
Last updated: 5 Dec 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Single-center Study to Explore the Relative Bioavailability and the Effect of Food on the Bioavailability of Prolonged Release Tablets Compared to Immediate Release Capsules Each Containing 60 mg of GRTA9906 in 20 Healthy Female Volunteers
ClinicalTrials.gov ID: NCT03765801
Acronym / sponsor ID: HP9906/06
Conditions: Pain, Neuropathic Pain, Chronic Pain, Visceral Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Grünenthal GmbHIndustry (pharma, biotech, devices)
Study start: 22 Oct 2003 (actual)
Primary completion: 11 Dec 2003 (actual)
Study completion: 11 Dec 2003 (actual)
First posted: 5 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
GRTA9906 60 mg PR tablet (fed)	Experimental	Drug: GRTA9906 60 mg PR tabletParticipants will receive two 60 mg GRTA9906 PR matrix tablets under fed conditions after consumption of a high-fat and high-calorie test meal.
GRTA9906 60 mg PR tablet (fasting)	Experimental	Drug: GRTA9906 60 mg PR tabletParticipants will receive two 60 mg GRTA9906 PR matrix tablets under fasting conditions (10 hours before dosing until 4.5 hours after dosing).
GRTA9906 60 mg IR capsule (fed)	Experimental	Drug: GRTA9906 60 mg IR capsuleParticipants will receive two 60 mg GRTA9906 IR capsules under fed conditions after consumption of a high-fat and high-calorie test meal.
GRTA9906 60 mg IR capsule (fasting)	Experimental	Drug: GRTA9906 60 mg IR capsuleParticipants will receive two 60 mg GRTA9906 IR capsules under fasting conditions (10 hours before dosing until 4.5 hours after dosing).

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Female Caucasian volunteers aged 18 - 55 years.
Body mass index between 18 and 29 kilograms per square meter inclusive.
Good physical and mental health status (no current acute illness) determined on the basis of the medical history and a general clinical examination.
Normal supine blood pressure (systolic blood pressure greater than or equal to 90 Millimeter mercury (mmHg) and less than or equal to 145 mmHg, diastolic blood pressure greater than or equal to 45mmHg and less than or equal to 90 mmHg) and pulse (greater than or equal to 45 and less than or equal to 90 beats per minute).
Electrocardiogram (12 lead) considered as normal by the Investigator.

Key exclusion criteria (17 listed)

Diseases and functional disorders of the gastrointestinal tract, hepatobiliary system, renal system or cardiovascular system including marked repolarisation abnormality (e.g. suspicious or definite congenital long QT syndrome) or co-medication that is known to influence cardiac repolarisation substantially.
Malignancy.
History of orthostatic hypotension.
Positive human immunodeficiency virus HIV1/2-antibodies, hepatitis B surface-antigen (HBs), hepatitis B core-antibodies (HBc), Hepatitis C virus (HCV) antibody tests at the prestudy medical examination.
Drug allergy.

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
GRTA9906 60 mg PR tabletGRTA9906 60 mg PR tablet	Drug	GRTA9906 60 mg PR tablet (fasting), GRTA9906 60 mg PR tablet (fed)
GRTA9906 60 mg IR capsuleGRTA9906 60 mg IR capsule	Drug	GRTA9906 60 mg IR capsule (fasting), GRTA9906 60 mg IR capsule (fed)

Primary outcome

Pharmacokinetic parameter - AUC0-tz
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Area under the concentration vs. time curve from dosing time to the last measured concentration above the lower limit of quantitation. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Pharmacokinetic parameter - AUC0-inf
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Total area under the concentration vs. time curve (from dosing time to infinity). The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Pharmacokinetic parameter - tmax
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Time to reach maximum serum concentration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Pharmacokinetic parameter - Cmax
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Maximum serum concentration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Pharmacokinetic parameter - lag-time (tlag)
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Period of time from the administration of the investigational product to the first measured concentration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Pharmacokinetic parameter - t(½,z)
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Apparent terminal half-life. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Pharmacokinetic parameter - MRT
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Mean residence time. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Pharmacokinetic parameter - HVD
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Half-value duration. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Pharmacokinetic parameter - CL/f
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Total clearance. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.
Pharmacokinetic parameter - Vz/f
Time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose
Apparent volume of distribution during the terminal phase. The concentration of GRTA9906 was determined in the serum samples using a validated HPLC-method with fluorometric detection.

4 secondary outcomes

Pupillometry parameter - Initial diameter (mm)
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Pupillometry parameter - Latency time (sec)
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Pupillometry parameter - Amplitude (mm)
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose
Pupillometry parameter - Constriction time (sec)
Time frame: pre-dose and 1, 2, 3, 4, 5, 6, 7, 8, 10 and 23 hours post-dose

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 5 Dec 2018.
Individual participant dataSharing planned: No

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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.

Grünenthal Study Director study director

Grünenthal GmbH

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 GRTA9906 60 mg PR tablet and GRTA9906 60 mg IR capsule in people with Pain and Neuropathic Pain, run by Grünenthal GmbH at 1 site in Germany.

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 10 inclusion and 17 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 5 Dec 2018. 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 Germany. 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?

Pharmacokinetic parameter - AUC0-tz (time frame: pre-dose, 5, 10, 20, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 13, 16, 20, and 23 hours post-dose). 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?

On the ClinicalTrials.gov record for NCT03765801.

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 5 Dec 2018.